Medical Device
- Development Engineer
- Newton, MA Michael Page
- 3.7 Newton, MA Job Details $100,000
- $125,000 a year 1 day ago Qualifications Biomedical engineering experience within healthcare FDA submissions Bachelor's degree in mechanical engineering 3D CAD modeling Engineering testing ISO standards 5 years Engineering Bachelor's degree in biomedical engineering Mechanical Engineering Project timeline management Biomedical Engineering GD&T Analysis skills Usability FEA Design for manufacturability (DFM) Design controls Regulatory submissions Manufacturing OEM Senior level Cross-functional collaboration Project leadership Project scheduling Cross-functional communication Engineering validation New product launch experience Mechanical product development projects Full Job Description Lead end-to-end development of spinal instrument systems.
Work hands-on across CAD, testing, surgeon feedback, and design. About Our Client The client is a fast-growing, innovation-driven medical device company within the spinal implants and instrumentation space. They are known for developing complete spine systems with a strong emphasis on surgeon usability, clinical feedback, and differentiated instrument design.
Job Description Responsibilities:
Lead product development from concept through commercialization in compliance with FDA and ISO design controls Design complete instrument systems supporting lumbar (TLIF, PLIF, LLIF, ALIF) and cervical (ACDF) fusion procedures Collaborate directly with U.S. spine surgeons and KOLs to gather feedback and customize instruments to surgical workflows Participate in cadaver labs and OR observations to improve usability, ergonomics, and workflow efficiency Partner closely with implant design teams to ensure seamless instrument-implant compatibility Perform CAD design and modeling, incorporating biomechanics, GD&T, and DFM principles Manage project timelines, risks, and cross-functional communication across engineering, quality, regulatory, and manufacturing Support verification, validation, testing, FEA, and mechanical evaluations Create and maintain DHF documentation, specifications, drawings, and risk management files Support regulatory submissions (e.g., 510(k)) and post-market engineering 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 Applicant Ideal Candidate:
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field 5-7+ years of experience developing medical devices with a strong focus on spinal or orthopedic instruments Direct experience working with U.S. spine surgeons on instrument development and optimization Strong background designing spinal instrument systems (trials, inserters, distractors, reduction tools, MIS instruments) Proficient in CAD software, GD&T, and tolerance stack analysis Solid understanding of design controls, usability engineering, risk management, and FDA regulatory pathways Experience at a major spine company (e.g., large or mid-sized spinal OEM) strongly preferred What's on
Offer What's To Offer:
Competitive compensation package with bonus and long-term incentives High-visibility technical leadership role with significant design ownership Direct influence on surgeon-facing products and surgical workflow innovation Opportunity to work on full spine systems from early concept to market launch
