Engineering Manager- Medical Device- Bedford, MA
The Engineering Manager will be a key hire to manage processes from beginning design phases all the way through production efforts. They will be a leader on the team to develop a smooth processes and life cycle of all products across Class I, II and III. Client Details The medical device manufacturer is a growing global company with a small presence here in Massachusetts. They are a top contributor across vascular technology as they continue to grow their product line of over 90 different products. Description Manage and mentor a team of Engineer (currently two direct reports). Lead hands-on development and revision of testing protocols and reports to maintain regulatory compliance with current and emerging industry standards for Class I, II, and III medical devices. Collaborate closely with Regulatory Affairs and Quality teams to ensure all applicable standards are up to date and fully implemented across the product portfolio. Perform gap assessments on product technical documentation and provide actionable recommendations for improvement. Initiate or guide change orders to implement required product or documentation updates. Participate in the CAPA process as it relates to product conformance and risk mitigation. Develop strong partnerships with cross-functional leaders to ensure alignment, efficiency, and effective execution of business needs. Ensure customer requirements are accurately captured and translated into feasible design changes that can be verified and validated through proper testing and manufacturing processes. Ensure all projects are executed in accordance with regulatory requirements (e.g., GMP, ISO, MDD/MDR) and internal policies and procedures. Document and share knowledge gained throughout projects to continuously improve product development processes and systems. Secure necessary resources from internal groups or external partners to ensure project success. Provide support in related areas as organizational needs arise. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants. Profile A successful Manager of Product Life Cycle Engineering should have: Bachelor's degree in a technical discipline, preferably with a focus in biomedical engineering or an equivalent field. At least 6 years of product development experience, demonstrating the ability to contribute to or lead the development of technologically complex products from concept through launch. Strong problem‑solving skills and the ability to execute effectively, delivering creative solutions that meet project goals. Demonstrated ability to manage and balance schedule, cost, and quality requirements. Solid understanding of new product development workflows and/or change management methodologies within regulated environments. Excellent communication, collaboration, and influencing skills across cross‑functional groups. Proven ability to deliver results in dynamic or ambiguous settings. Experience guiding or leading self‑directed teams. Working knowledge of relevant regulatory and quality frameworks such as ISO 13485, ISO 14971, and FDA GMP/QSR. Ability to work onsite as needed based on role responsibilities. Job Offer Competitive annual salary ranging from $130,000 to $175,000. Comprehensive benefits package, including health, dental, and vision insurance. Opportunities for professional growth and development. Inclusive and supportive company culture. Paid time off and flexible work arrangements. If you are ready to take the next step in your career as a Engineering Manager, we encourage you to apply today. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
