Principal Medical Device Engineer

Our client is seeking a Principal Medical Device Engineer to serve as the technical lead for injector and drug delivery device development programs. This individual will provide hands‑on engineering leadership across product development activities, supplier engagement, risk management, testing, and commercialization efforts while partnering closely with cross‑functional teams to advance combination products. This role is onsite 5 days/week in the greater Boston area. Responsibilities Lead injector and medical device development projects from concept through commercialization. Provide technical leadership for design, testing, risk management, and product lifecycle activities. Drive mechanical design evaluations, tolerance analysis, testing strategies, and manufacturing readiness. Partner with suppliers, contract manufacturers, and development partners to support device development and issue resolution. Lead risk management activities including FMEA, hazard analysis, and mitigation planning. Support design controls, DHF documentation, verification/validation, and regulatory submissions. Collaborate with Quality, Regulatory, Manufacturing, Clinical, and Human Factors teams to ensure successful product development and compliance. Mentor engineers and contribute to technical strategy and decision‑making. Qualifications BS or MS in Mechanical Engineering, Biomedical Engineering, or related discipline. 10+ years of medical device product development experience. Demonstrated experience leading injector, drug delivery, or combination product development programs. Strong proficiency with SolidWorks and mechanical design principles. Hands‑on experience with mechanical testing, tolerance analysis, injection molding, packaging development, cleaning/process validation activities, and risk management (FMEA, Hazard Analysis). Experience working with suppliers, CMOs, and external development partners. Strong verbal communication skills with the ability to lead technical discussions across internal and external stakeholders. Experience supporting products through design controls, verification/validation, and commercialization. Preferred Qualifications Combination product experience within pharmaceutical or biotechnology environments. Ophthalmic, injectable, or drug delivery device experience. Experience with DHF remediation and compliance with 21 CFR Part 4, 21 CFR 820, ISO 13485, and ISO 14971. Project leadership experience managing timelines, deliverables, and cross‑functional teams. #J-18808-Ljbffr Redbock - an NES Fircroft company