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Sr. Manufacturing Engineer

North Waltham, MA 02452

Posted: 05/24/2022 Employment Type: Direct Hire Category: Engineering Job Number: 62084 Pay Rate: 130,000

Job Description

Are you passionate about working with products which save lives on a daily basis? Have you worked in manufacturing environments as an Engineer on DVT (Design Validation Testing)? Do you enjoy working as a leader responsible for collaboration with suppliers and outside contract manufacturers in a dynamic and growing company? If this sounds like you, apply with your resume to this posting today! Disruptive technology medical device company growing in Eastern Massachusetts, be a part of something big!

Position Summary
The Senior Advanced Manufacturing Engineer will be a key contributor to design and development of manufacturing processes and procedures in collaboration with the chosen contract manufacturers of medical device products. The Senior Advanced Manufacturing Engineer will be responsible for engineering support of all pre-DVT, DVT and commercial production of product designs including procurement, inspection, assembly process, test processes, and supplier engineering.
This role will be part of a cross-functional team developing best practices for manufacturing processes and will help to develop, establish, and maintain methodologies, systems, and practices within the  quality management system.
Responsibilities
• Own and support the implementation of effective manufacturing process instructions and controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as business objectives.
• Function as the lead technical liaison to Contract Manufacturing and Suppliers. Representing manufacturing in all internal quality processes including CAPA systems, Non-Conformances, Complaints, and Internal and External quality audits
• Apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of manufacturing issues and to assist in the risk management and risk-based decision processes
• Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures
• Write manufacturing procedures; develop Bills of Material.
• Lead improvement or enhancement to manufacturing, quality systems and processes. Collaborate in the development of quality/business system procedures, processes, and tools to support the corporate continuous improvement activity.
• Provide Direct manufacturing engineering support of product characterization, pre-DVT, DVT and commercial production of product at outsourced finished product and disposables manufacturing including participation in process improvement initiatives.
• Review and Validate protocols that adequately determine product or process conformance to user needs and specifications.
• Provide support in Supplier management and compliance through the supplier approval process, quality plan implementation, supplier surveillance, performance measures and audits.
• Lead the procurement and materials management of all parts and components for pre-DVT including the ASL and ongoing supplier qualification
• Be responsible for component engineering and specification and problem resolution with suppliers. Provide technical guidance to suppliers towards assuring product/process compliance with engineering drawings, requirements, and specifications
• Monitor non-conformance performance / trends, and identify and drive process improvement, root cause analysis, and corrective actions
• Occasionally travel to supplier sites to support audit or corrective action activities
• Participate in all characterization and pre-DVT builds to ensure correctness and continuous improvement of MPIs to be used in the DVT build.
• Influence the design of new products from the experience and findings of the build activity
• Be a key Quality team member in preparation and participation in all external audits and inspections from Certification and Notified bodies as well as worldwide Regulatory agencies.
• Own the transfer of supplier management and manufacturing and test processes to Contract Manufacturer partners.
• Support V&V testing as required
Experience
• Requires a minimum of 7-10 years related experience in Medical Device, Automotive or similar industry
• Requires a Bachelor/Masters degree or equivalent in engineering or related discipline
• Familiarity with complex pneumatics
• Experience with the design and/or manufacturing of complex electro-mechanical products
• Ability to properly document development activities in a regulated environment
• Familiarity with mechanical dimensioning and tolerancing, and interpretation of component specifications
• Strong written and interpersonal communication, partnering and relationship building cross-functionally within the organization
• Proven record of working within the FDA Quality System Regulation (ISO 13485)
• Demonstrated understanding of Quality tools/methodologies with outstanding organizational skills including strong attention to detail and follow-through
• Fluent in the application of sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
• Experience and knowledge of performing product design verification and validation, developing and validating test methods, and transferring products to manufacturing
• A working knowledge of reliability and quality engineering techniques such as Lot Acceptance Testing, Fishbone Diagrams, etc
• Proficiency in Microsoft Office Suite and similar business software applications is required
• Six Sigma Black Belt preferred
• SolidWorks or OnShape experience is preferred

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    DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace.   We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be.   Apply today and experience “ The DAVIS Difference”. 
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As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.