Senior Medical Device Product Development Engineer

Forj Medical; Saint Paul (MN); On-site; USD 85,000 - 115,000; Full time

Job summary

Forj Medical is seeking a Product Development Engineer III to drive the design and development of Surgical Navigation products from concept to commercialization. You will translate clinical and user needs into engineering requirements and manage cross-functional activities ensuring design controls and quality systems compliance.

The role requires 5+ years in medical device product development, proficiency with SolidWorks, GD&T, and strong problem-solving abilities.

Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
• 5+ years of product development experience, preferably in the medical device industry.
• Experience developing mechanical and/or electromechanical products in a regulated environment.
• Strong knowledge of design controls, risk management, and regulated product development processes.
• Proficiency with SolidWorks or similar 3D CAD software, including GD&T and engineering drawing creation.
• Experience creating engineering documentation, including drawings, specifications, BOMs, DHF deliverables, and verification/validation documentation.
• Experience supporting FDA submissions, including 510(k) and/or PMA programs.

Responsibilities

• Lead the design, development, and optimization of Medical Device & Surgical Navigation products from concept through commercialization.
• Translate customer, user, and clinical needs into product requirements, engineering specifications, and design inputs.
• Coordinate prototyping, testing, and analysis activities to assess product performance and reliability.
• Ensure documentation is complete, accurate, and compliant with quality system requirements.
• Develop and execute verification and validation strategies, plans, protocols, and reports.
• Coordinate prototype, engineering, and production-intent builds.
• Collaborate with Quality, Regulatory, Clinical, Marketing, Manufacturing, Supply Chain, Program Management, and Operations teams.

Skills

Strong technical writing

Analytical skills

Problem-solving skills

Independent work

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline

Tools

SolidWorks

GD&T

Job description

Forj Medical is seeking a Product Development Engineer III to drive the design and development of Surgical Navigation products from concept to commercialization. You will translate clinical and user needs into engineering requirements and manage cross-functional activities ensuring design controls and quality systems compliance.

The role requires 5+ years in medical device product development, proficiency with SolidWorks, GD&T, and strong problem-solving abilities.