Design Engineer Supervisor

Position SummaryThe Design Engineer Supervisor leads the development of innovative medical device products from concept through commercialization. This role combines hands-on technical execution with team leadership and regulatory oversight to ensure all products meet performance, manufacturability, cost, usability, and sustainability objectives.The Supervisor is accountable for executing the full Design Control process in compliance with ISO 13485:2016 and FDA 21 CFR Part 820 (QMSR) requirements. This position serves as the technical authority for design decisions, risk management, and development documentation while mentoring and directing the engineering team.Key ResponsibilitiesTechnical & R&D Leadership Lead cross-functional design and development activities through all phases of the product lifecycle (concept, design, verification, validation, and transfer to manufacturing). Define technical objectives, project milestones, and engineering deliverables aligned with business and regulatory requirements. Direct complex engineering analyses including FEA, fatigue analysis, DFMA, FMEA, tolerance analysis, and DOE to ensure product robustness and manufacturability. Approve engineering drawings, specifications, and validation protocols prior to release. Regulatory & Quality Compliance Ensure all development activities comply with ISO 13485:2016 and FDA 21 CFR Part 820 (QMSR). Oversee completion and maintenance of Design History Files (DHF), Device Master Records (DMR), risk management files, and traceability matrices. Lead technical review of non-conformances (NCRs), participate in Material Review Board (MRB) activities, and drive root cause investigations for internal and customer issues. Support audits, CAPA investigations, and regulatory submissions as required. Manufacturing & Continuous Improvement Collaborate with Manufacturing Engineering to optimize processes for yield, automation, sterilization compatibility, and cost efficiency. Utilize field performance data, reliability analysis, and customer feedback to drive iterative design improvements. Champion DFMA principles and sustainable engineering practices. Supervisory Responsibilities Provide daily direction, mentorship, and technical coaching to the design engineering team. Assign work packages, manage priorities, and track progress against timelines and budgets. Conduct performance evaluations and foster a culture of accountability and continuous development. Participate in workforce planning, candidate interviews, hiring decisions, and onboarding of new engineers. Serve as primary technical escalation point for complex engineering challenges. QualificationsEducation & Experience Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Materials Engineering, or related field (Master's preferred). 5+ years of medical device product development experience under a regulated QMS environment. Experience with metals or reusable surgical instruments preferred. Technical Expertise Advanced proficiency in SolidWorks (3D modeling, assemblies, drawings, GD&T) within a PDM environment. Strong mechanical engineering fundamentals (statics, dynamics, strength of materials, stress analysis, FEA). Experience designing plastic components and assemblies. Demonstrated hands-on experience with prototyping, testing, verification, and validation activities. Working knowledge of design inputs/outputs, traceability, risk management, and documentation control. Familiarity with statistics, DOE, and data-driven decision making. Leadership & Professional Skills Proven ability to lead cross-functional teams and resolve conflicting technical requirements. Strong problem-solving skills and root cause analysis capability. Excellent written and verbal communication skills, including technical documentation and presentation. Ability to balance hands-on engineering with strategic oversight. Pay Details: $130,000.00 to $150,000.00 per yearEqual Opportunity Employer/Veterans/DisabledMilitary connected talent encouraged to applyTo read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Created: 2026-03-17