Massachusetts

  • Senior Quality Manager
    Quality
    Devens MA

    Responsible for the operation of the Quality Department, and ensuring the effectiveness and maintenance of SMC Ltd quality management system, both ISO 9001:2000 and 2003:13485 and any other certifications chosen by management. Determine, and execute on, strategic initiatives for the Quality organization. Proficiently develop detailed reports providing forecasting trending and result analysis tools vital to SMC’s short and long term strategic business planning. Manage the Quality function supporting the manufacturing of a variety of products at multiple manufacturing sites. Assure product quality is in conformance with customer expectations, engineering specifications and regulatory requirements and effectively relate the Quality function to the business as a whole. Regular attendance and Professionalism. Lead the development and continuous improvement of Quality division-wide driving internal improvements while meeting customer requirements. Oversee implementation and maintenance of SMC Quality policies and systems. Design and implement on-going employee quality control training programs. Develop new strategies and suggest new and alternate measuring equipment for SMC. Responsible for all aspects of the QMS including Management Review and Internal Auditing functions. Direct the updates as others maintain the quality control manual to SMC current policies, systems. Maintain budgets and departmental financial targets as outlined by management. Ensure completion of all customer requests corresponding to questionnaires and audits. Responsible for maintaining a safe work environment by following all company safety policies and procedure. Perform any and all other duties assigned. QUALIFICATIONS: Bachelor’s degree in a related field or suitable work experience. Minimum of 10 years’ experience as a QC/QA Manager or QE in the medical device or components industry. Experience with internal and external auditing. Experience with clean room manufacturing. Knowledge of SPC and its computer applications. Knowledge of IQ/OQ/PQ; FMEA; PPAP; Control Plans and Validation Plans. Knowledge of ISO-9001 & 13485 AND CGMP’s. Excellent written, verbal and presentation skills. Ability to lift and to bend to move up to 50 lbs. Ability to read, write and communicate in English.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any  other protected category that is unlawful to discriminate against under federal, state, and/or local laws.  This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Senior Process Engineer
    Engineering
    Devens MA

    Direct the Process Engineering Team with regard to New Product Development. Develop optimum molding processes for manufacturing medical components. Provide recommendations and implement improvements to processes and manufacturing methods for new projects and existing production processes, methods and controls. Lead and direct Process Engineering Team with regard to New Product Development efforts and support for Production Operations as required. Responsible for performing performance appraisals and developing appropriate training plans for Process Engineering Team. Coordinate Process Engineering efforts for New Developments in both Sterling and Leominster facilities. Coordinate with scheduling and develop testing plan and deploy team resources to achieve test workload. This may require staggered shifts, or flexible hours, or on person working 2nd shift to achieve high points in workload. Train and Mentor Process Engineering team to achieve and maintain appropriate levels of skills required. Implement usage RJG E-Dart’s and instrumented molds, Scientific Molding Techniques and Decoupled Molding. Train and develop a mold setter/material handler to prep samples in advance, with a long term objective to develop good process technicians. Responsible to perform mold and process testing for mold debug, process development, and validation studies. Develop, document, and implement standard manufacturing processes and methodologies. Perform research, design and develop manufacturing processes and new technologies. Recommend and improve manufacturing processes and methods for cost reduction, quality improvement and efficiency. Work with design, manufacturing, production, engineers and tooling during the entire development cycle. Participate in Tool Design Reviews and recommend improvements to optimize molding, setup, and overall manufacturing. Troubleshoot molding and manufacturing processes and material issues. Work with internal and external resources to resolve molding and manufacturing issues and implement long term solutions. Research, develop, and implement manufacturing process controls, machinery modifications and improvements. Provide input on new or alternate materials for cost reduction or molding improvements. Other duties as assigned.

    QUALIFICATIONS: Bachelor of Science degree in Plastics Engineering. A minimum of 5 years related experience or equivalent combination of education and experience. Production processing experience in injection molding. Understanding and experience implementing decoupled molding processes and scientific molding techniques. Understanding of mechanical assembly processes and injection mold tooling. Technical skills in manufacturing processes and methods including process flow, cell layout, assembly and production equipment. Ability to organize, prioritize and manage multiple tasks. Excellent interpersonal and communication skills. Strong team player, self-motivated. Excellent problem solving skills with attention to detail. Excellent written, verbal and communication skills. Computer proficient. Ability to read, write and communicate in English. Exerting up to 50 pounds of force occasionally and/or a negligible amount of force constantly to move objects. Ability to work for extended periods of time sitting and looking at a computer while completing repetitive motions to include substantial movements (motions) of the wrists, hands and/or fingers. Close visual acuity to perform an activity such as preparing and analyzing data and figures; reviewing detailed information; viewing a computer terminal; and expansive reading. The ability to manage a number of projects at one time with frequent interruptions and tight deadlines.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any other protected category that is unlawful to discriminate against under federal, state, and/or local laws. This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Program Manager
    Engineering
    Devens MA

    Manage the development of new projects from quotation support, through development and validation of molds, equipment, and manufacturing processes, and successful transfer to Manufacturing. Lead project and SMC project team that supports the development efforts of a new project. Work with internal and external resources to research, design, and develop the all of the necessary elements of the project – molds, tooling, processes, automation, fixtures, EOAT, secondary equipment, etc. Effective use of personal and team, and organizational communication. Develop project timelines that support our quoted lead-times, and incorporate the customer requirements for validation, pilot builds, and approval. Manage project to ensure that we meet the customer deliverables and complete a successful development so that we meet the quality and financial requirements of the project. Deploy good project management techniques with internal and external teams – Action item lists, meeting minutes, strong communication skills, setting priorities, seeking other assistance as required. Be the primary technical interface with customer. Gather product requirements from the customer. Review product design for compliance with engineering principles, engineering standards and customer requirements and specifications. Provide technical support and input in the areas of product design, material selection, mold design, manufacturing, secondary operations, validations and other areas related to our industry. As the primary interface good communication skills and responsiveness are required. Ensure that mold, process, or assembly testing is performed in a manner that will give us a thorough development, and a robust manufacturing process. Determine test and DOE objectives. Resolve issues that are found during testing. Write and review reports as related to the project including validation reports and summaries. Develop and gather all the necessary documentation during the project set-up and development phases. Develop the Device Master Record (DMR), and ensure that internal documentation and systems are up to date at the time of the Release to Manufacturing (RTM). Provide internal support for the project after RTM, and resolve any new issues that develop. Support the sales effort by providing technical expertise and identifying potential new opportunities with existing customers. Support the quoting phase of the project as requested. Responsible for maintaining a safe work environment by following all company safety policies and procedures. Other duties as assigned. QUALIFICATIONS: Bachelor of Science Degree in Engineering, preferably Plastics. A minimum of five years of experience preferred in the Plastics Industry, preferably Injection Molding. Capable of Multi-tasking, organized, excellent time management skills. Must have excellent written and verbal communication skills to handle sensitive and confidential situations. Strong technical and proposal writing skills. Must have strong presentation skills. Ability to exercise strong judgment in analyzing, evaluating and solving problems. Exerting up to 50 pounds of force occasionally and/or a negligible amount of force constantly to move objects. Ability to work for extended periods sitting and looking at computer while completing repetitive motions to include substantial movements (motions) of the wrists, hands, and/or fingers. Close visual acuity to perform an activity such as preparing and analyzing data and figures; reviewing detailed information; viewing a computer terminal; and expansive reading. The ability to manage a number of projects at one time with frequent interruptions and tight deadlines. This position may supervise employees.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any other protected category that is unlawful to discriminate against under federal, state, and/or local laws. This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Production Lead - 1 for A Crew, 1 for B Crew, and 1 for D Crew
    Operations
    Devens MA

    Provide hands-on leadership for all molding room floor personnel in support of safety, compliance, productivity, quality standards and company policy. Monitor/adjust work of shift employees to schedule demands. Recommend improvements in production methods, equipment, operating procedures and working conditions and equipment. Responsible to uphold cleanliness standards. Support sustaining (Set-In-Order) standards for general work areas of the molding operation. Provide and maintain skill set necessary to properly operate, inspect and package product on the molding room floor. Drive expectations (Set-In-Order) “clean and tidy” standards for all work areas. Set up Assembly, Packaging, and Test equipment per validated processes to produce medical devices or sub-assemblies. Work with Quality Technician for start-up approval of production lines. Monitor and provide ongoing feedback regarding the daily performance of shift employees and help to ensure product conformance to customer specifications and scheduled delivery dates, while helping to monitor quality, production, scrap, safety, and cost and customer service for the shift. Perform initial and refresher training for temporary and full time employees to proper work methods per specifications and standard work instructions (SWI’s). Adhere to clean room processes and procedures. Set up, troubleshoot and assist in resolving process/equipment problems. Monitor processes, policies and procedures and recommend improvements in production methods, equipment, operating procedures, working conditions (safety, quality, productivity, and cost) and cost effectiveness. Work closely with customer service, quality, scheduling and various other departments to ensure production and quality of products meets specifications and delivery times. Post daily production, daily scrap, and monitor inventory of product used. Maintain lot traceability and perform line clearance and reconciliation, as required. Investigate and resolve production material variances. Perform Corrective and Preventative Action duties (CAPA), Continuous Improvement and 6S Lean activities as assigned. Where errors exist, revise/write standard work instructions for review, approval and submission to document control. Qualifications: Demonstrated abilities in prioritization, multi-tasking, problem solving while maintaining strong attention to detail and willingness to collaborate in a team environment. Excellent customer service skills, communication skills, comprehensive and troubleshooting skills are necessary. Able to skillfully navigate obstacles to generate positive outcomes. Strong interpersonal and communication skills; be a team player; and have the ability to develop a team atmosphere. Must be able to communicate with all levels of staff. Ability to understand and practice company and customer quality requirements. Knowledge and practical understanding of various assembly methods and secondary operations equipment. Knowledge of equipment setup, operating techniques, and troubleshooting. The ability to visualize and help design/develop tools, fixtures, processes to obtain maximum efficiency. Working knowledge of ISO, FDA, GMP, and OSHA standards. Technical background desirable. Competent in the use of computers, basic Microsoft Office Suite, bar code readers, with the ability to access and enter data as necessary. Ability to read, write and communicate in English. High School Diploma or equivalent required.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any  other protected category that is unlawful to discriminate against under federal, state, and/or local laws.  This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Inspector Packer - 1 for A Crew, 1 for B Crew, 1 for C Crew
    Operations
    Devens MA

    Operate equipment to meet daily production requirements while meeting all quality expectations and safety standards. Inspect production and package product. Follow daily schedules, SWI’s, and SOP’s to produce devices or components that comply with customer specifications. Kit and stage the necessary components for upcoming work orders. Track the daily cell production. Set up equipment (i.e. tables, scales, fixtures, etc.) to meet daily production needs. High School diploma or equivalent required.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any  other protected category that is unlawful to discriminate against under federal, state, and/or local laws.  This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Facilities Maintenance Mechanic - 1st Shift
    Facilities Maintenance
    Devens MA

    Perform technical and mechanical functions as directed by the Facilities Manager for the purpose of operating the properties in a manner consistent with maximum efficiency, cost effectiveness servicing all SMC East facilities. Perform all necessary building design, mechanical maintenance and operational procedures to assure maximum efficiency. Act as a lead in managing projects that could include outside vendors and associates. Must possess the ability to communicate effectively and clearly with management team, vendors, associates and visitors. Maintenance of Commercial HVAC, basic plumbing, maintenance of electrical systems. Must have knowledge of basic carpentry and build out design using Auto CAD/Solid Works. Plan, layout, and installation of a wide array of facility and production equipment and perform tear down and setup of office space cubicles. Maintenance and repair of central drying systems, clean room pm and installation of drop ceilings and HEPA systems. Other duties include clean room monitoring, pest control monitoring, storm emergence response and clean up. Must comply with OSHA safety regulations. Regular attendance, professionalism, and other duties as required. QUALIFICATIONS: Certificate from a two year college or technical school or a minimum of five years related experience and/or training; or equivalent combination of education and experience. Strong mechanical ability. Must have a valid driver’s license, and the ability to provide a good driving record. The ability to read, write and understand English.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any other protected category that is unlawful to discriminate against under federal, state, and/or local laws. This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Component Stager/Service - 1 for C Crew
    Operations
    Devens MA

    Prepare resin and non-resin sub-components for scheduled work centers on the molding room floor. Deliver sub-components directly to Work Cells. Retrieve product from Work Cells to the packing area outside the molding room. Final box, fable, palletize and ready product for the warehouse. Set up and manage resin preparation, delivery, and all ancillary equipment both in the preparation and press side job sites. Perform line clearance of all components/equipment at the end of work orders and for the return of unused sub components to inventory in IQMS. Key accountabilities/essential functions: Accurate and timely resin material preparation, delivery, and retrieval to the correct work centers. Accurate and timely materials staging for production job(s) to the correct work centers. Accurate retrieval and packaging or finished/WIP product from work cells. Accurately move transactions in the IQMS system. Cleanliness management of preparation sites and press side charging operations. Compliance to company Policy, Federal OSHA regulations, and industry cGMP expectations. Regular attendance and professionalism. Properly package and label parts and product. Maintenance of grinder equipment and scrap preparation for disposal. Load, unload, and stack materials and product.

    Qualifications: High School Diploma or equivalent required. Demonstrated abilities in prioritization, multi-tasking, problem solving while maintaining strong attention to detail and willingness to collaborate in a team environment. Embraces teamwork. Production experience required. Ability to follow oral and written instructions and to read, write and communicate in English. Ability to read and interpret DHRs (Device History Record). Proficient mathematical skills to successfully complete tasks. Knowledge and use of scales. Forklift experience preferred (position must be SMC Forklift Certified before operating forklift). Competent in the use of computers, basic Microsoft Suite software, bar code readers, with the ability to access and enter data as necessary. Knowledge of IQMS preferred.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any other protected category that is unlawful to discriminate against under federal, state, and/or local laws. This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Class A Master Electrician
    Operations
    Devens MA

    Perform electrical functions that are not limited to and include installation, repair and maintenance. Performs the work of installing, repairing or maintaining wires conduits, apparatus, devices, fixtures or other appliances used for light, heat, power, fire warning or security system purposes. Knowledge of control systems; Color Vision: The ability to work with colored coded wiring and be able to identify them by sight. Troubleshooting: Must be able to find the root cause of issues and think logically about solutions. Customer Service: The ability to work with many different customers simultaneously while projecting a friendly, professional image while working on site. Critical Thinking: Must have the ability to think critically in the process of repairing the issue when diagnosing problems. Mechanical Skills: Proficiency in reading blueprints and schematics while using an array of tools and diagnostic devices to service and install electrical parts. Work at the construction level to install and test new equipment and systems while repairing and maintaining older, pre-existing systems. Regular attendance and professionalism are required. Perform other duties as assigned. Qualifications include: Licensure as a Master Electrician. The ability to read, write, speak and understand English.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any other protected category that is unlawful to discriminate against under federal, state, and/or local laws. This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.

  • Cell Lead - 2 for A Crew
    Operations
    Devens MA

    Work hands-on with Operators to ensure product compliance. Coordinate all cell activities through Production Leader. Perform Production Reporting duties as required. Responsible for upholding cleanliness in all areas of assigned work cell on a daily basis. Run the presses and work the assembly stations on the production floor. Perform Role of Inspector/Packer at least 85% of the time in their assigned cell. Own and maintain press scrap. Verify that defective parts in (red) defect bins are reported hourly on appropriate metrics (tally sheets, pulse boards) and identified by defect. Maintain (Set-In-Order) “clean and tidy” standards for all assigned work areas. Regular attendance and professionalism. Perform 6S and Lean activities as assigned. Provide front line leadership ensuring customer satisfaction. Perform Production Reporting and other Administrative duties. Perform inspection of product produced in the work cell. Pack parts, weigh parts, make labels, assure parts are packed properly. Support leads with work order changes. Assure production tally sheets are accurate with back counts. Elevate to Production Leads/Supervisor issues concerning part quality and paperwork compliance. Maintain efficiency, housekeeping and safe work environment. Perform other duties as required. QUALIFICATIONS: Demonstrated abilities in prioritization, multi-tasking, problem solving while maintaining strong attention to detail and willingness to collaborate in a team environment. High School Diploma or GED. The ability to follow oral and written instructions and to understand, speak and read English. Minimum one year of experience in production environment, preferably in plastics. Good communication, computer and counting skills. The ability to lift 50 pounds, stand throughout a twelve (12) hour shift, stoop, bend and stretch; tolerate temperatures in excess of 80 degrees at times and gowning requirements. Position also requires working in proximity to moving equipment, chemical scents and noise at times. This position utilizes all production equipment, hand tools, the computer, scanners, printers, telephone, calculator, and other general office equipment. Interacts with all levels of employees, customers and auditors. An executed non-disclosure agreement is required prior to start date.

    SMC will provide equal opportunity in employment practices to all employees and applicants for employment in accordance with all applicable federal, state or local equal employment opportunity/affirmative action laws. Employment decisions shall be made without regard to race, color, creed, religion, age, sex, sexual orientation, gender identity or expression, national origin, ancestry, disability, pregnancy, marital or parental status, genetic information, arrest and/or conviction record(s), military service, disabled/protected/other veteran status, use or nonuse of lawful products off the employer’s premises during non-working hours, declining to attend a meeting or participate in any communication about religious matters or political matters or any  other protected category that is unlawful to discriminate against under federal, state, and/or local laws.  This policy applies to all areas of employment, including recruitment, advertising, hiring, training and development, promotions, transfers, terminations, demotions, layoffs, compensation and benefits, social and recreational programs, and all other conditions and privileges of employment in accordance with applicable federal, state, and local laws.