What are the responsibilities and job description for the Medical Device - Development Engineer - Newton, MA position at Michael Page?
- Lead end-to-end development of spinal instrument systems.
- Work hands-on across CAD, testing, surgeon feedback, and design.
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.
Responsibilities
Job Description
- 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
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 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
Quote job ref: JN-052026-7015620
Salary : $100,000 - $125,000