Save Job Back to Search Job Description Summary Similar Jobs2 direct reportspublicly traded and record Q4 revenueAbout Our ClientOur client is a global medical device organization with a diverse portfolio of over 90 commercial products spanning multiple therapeutic areas. With a strong international footprint and a proven track record of innovation, they combine the stability of a well‑established company with the agility of a fast‑growing operation.Their Greater Boston facility is a strategically important site focused on high‑impact engineering work, product support, and new product introduction. The team is currently in rapid expansion mode, fueled by a record-breaking Q4 revenue performance that has accelerated investment in talent, technology, and product development.Job DescriptionServe as the technical leader overseeing all engineering activities for both new product introduction and post‑market/sustaining engineering.Lead and mentor a team of two direct reports, providing technical guidance, performance feedback, and career development.Drive root-cause investigations, corrective/preventive actions (CAPA), and product improvements for commercialized devices.Partner with R&D teams to define product requirements, develop design solutions, support verification/validation, and ensure design transfer readiness.Ensure ongoing compliance with FDA, ISO, and other global regulatory standards across Class I, II, and III devices.Lead risk management activities (ISO 14971), including hazard analysis, FMEAs, and post‑market surveillance assessments.Collaborate with Operations and Manufacturing Engineering to address supplier issues, improve yields, reduce defects, and optimize production processes.Manage engineering documentation, design history files (DHF), device master records (DMR), and engineering change orders (ECOs).Support regulatory submissions by providing engineering data, technical rationales, and documentation.Champion continuous improvement across engineering workflows, design methodologies, and sustaining activities.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.The Successful ApplicantThe successful Principal R&D Engineer will have a background that follows: Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or related field.10+ years of engineering experience in the medical device industry, with substantial exposure to sustaining engineering and new product development.Demonstrated experience working with Class I-III medical devices.Strong understanding of design controls, risk management, and regulatory requirements (FDA, ISO 13485, IEC standards).Proven leadership experience, including managing or mentoring engineering staff.Excellent problem-solving ability with hands-on experience in root‑cause analysis and CAPA.Strong communication skills and ability to influence cross-functional teams.Ability to manage multiple projects simultaneously in a fast-paced, regulated environment.What's on OfferThe Principal R&D Engineer will be offered: Competitive Base Salary commensurate with experience and industry standards for Principal‑level engineering roles.Annual Bonus Program tied to individual and company performance.Equity or Long‑Term Incentive Plan (LTIP) depending on level and company policy.Comprehensive Health Benefits including medical, dental, and vision coverage.401(k) with Company Match to support long‑term financial planning.Generous Paid Time Off (PTO) including vacation, holidays, and sick time.Flexible Work Options, including hybrid schedules where applicable.Professional Development Support such as training, certifications, and conference attendance.Life & Disability Insurance fully or partially employer‑paid.Employee Wellness Programs and optional FSAs/HSAs.Opportunities for Career Advancement within a growing engineering and product organization.ContactJack DonahueQuote job refJN-022026-6938525Job summarySectorEngineering & ManufacturingSub SectorEngineering Design and R&DIndustryIndustrial / ManufacturingLocationBedfordContract TypePermanentConsultant nameJack DonahueJob ReferenceJN-022026-6938525
