Medical Device - Development Engineer - Newton, MA

Michael Page International

Newton, MA

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JOB DETAILS

SALARY

$100,000–$125,000 Per Year

JOB TYPE

Full-time

SKILLS

Biomechanics, Biomedical Engineering, CAD (Computer-Aided Design) Software, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Cross-Functional, Documentation, Ergonomics, FDA (Food and Drug Administration), FDA Requirements, Finite Element Analysis, Geometric Dimensioning and Tolerancing, ISO (International Organization for Standardization), Implants, Instrumentation, MPI, Management of Information Systems/Technology (MIS), Mechanical Engineering, Medical Equipment, OEM (Original Equipment Manufacturer), Orthopedics, Product Development, Regulations, Regulatory Submissions, Risk Management, State Laws and Regulations, Surgical Supplies, Systems Administration/Management, Technical Leadership, Usability Engineering, Validation Testing

LOCATION

Newton, MA

POSTED

1 day ago

This role is responsible for leading the design, development, and customization of spinal implant instrument systems from early concept through commercialization. The position integrates closely with implant design teams and works directly with U.S. spine surgeons to refine surgical workflows, ergonomics, and system performance. The engineer will play a critical role in shaping surgeon-facing instrumentation for fusion procedures. Client Details 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. Description Responsibilities:Lead product development from concept through commercialization in compliance with FDA and ISO design controlsDesign complete instrument systems supporting lumbar (TLIF, PLIF, LLIF, ALIF) and cervical (ACDF) fusion proceduresCollaborate directly with U.S. spine surgeons and KOLs to gather feedback and customize instruments to surgical workflowsParticipate in cadaver labs and OR observations to improve usability, ergonomics, and workflow efficiencyPartner closely with implant design teams to ensure seamless instrument-implant compatibilityPerform CAD design and modeling, incorporating biomechanics, GD&T, and DFM principlesManage project timelines, risks, and cross-functional communication across engineering, quality, regulatory, and manufacturingSupport verification, validation, testing, FEA, and mechanical evaluationsCreate and maintain DHF documentation, specifications, drawings, and risk management filesSupport regulatory submissions (e.g., 510(k)) and post-market engineering activities Profile Ideal Candidate:Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or related field5-7+ years of experience developing medical devices with a strong focus on spinal or orthopedic instrumentsDirect experience working with U.S. spine surgeons on instrument development and optimizationStrong background designing spinal instrument systems (trials, inserters, distractors, reduction tools, MIS instruments)Proficient in CAD software, GD&T, and tolerance stack analysisSolid understanding of design controls, usability engineering, risk management, and FDA regulatory pathwaysExperience at a major spine company (e.g., large or mid-sized spinal OEM) strongly preferred Job Offer What's To Offer:Competitive compensation package with bonus and long-term incentivesHigh-visibility technical leadership role with significant design ownershipDirect influence on surgeon-facing products and surgical workflow innovationOpportunity to work on full spine systems from early concept to market launch 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.

About the Company

Michael Page International

Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world. Our business was established in Canada in 2005 when we opened our Toronto office. Our role is to work with employers and job seekers to facilitate a successful match. This can range from advising a global company on a candidate sourcing strategy to helping a job seeker find their dream job. In Canada, we focus on recruiting for the following areas: Banking and financial services Digital and e-commerce Engineering and manufacturing Finance and accounting Human resources Information technology Marketing Oil and gas Procurement and supply chain Property and construction Sales An Established Brand The Group has established a leading presence in many of the key markets for professional recruitment around the world and has positioned itself in certain other markets, which offer the opportunity for future growth. Within its current largest markets, Michael Page has also built a regional presence, including in the UK, France and Australia. Consequently, the Michael Page brand is among the most widely recognized brands in the professional recruitment industry. A Market Leader The role of a recruitment consultancy is to act as an intermediary, identifying and sourcing suitably qualified candidates on behalf of its clients. Candidates are recruited either for permanent or contract positions (typically for a fixed term) or on a temporary basis. Within the overall recruitment industry, the market for professional recruitment services is a specialist sector which has developed more recently. Michael Page is widely recognized as leading the development of this market around the world. Learn the benefits of working with Michael Page yourself. Submit your resume or contact a Michael Page recruitment consultant today.

COMPANY SIZE

10,000 employees or more

INDUSTRY

Staffing/Employment Agencies

WEBSITE

https://www.michaelpage.ca/

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