Senior Medical Device Product Development Engineer

Forj Medical; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Health insurance

Dental & vision insurance

401K plans

Time off programs

Annual bonus program

Job summary

Forj Medical is seeking a Product Development Engineer III to lead the design and development of Surgical Navigation products from concept through commercialization. You will transform clinical needs into engineering requirements, drive verification/validation, and maintain design controls to ensure compliant medical devices.

You will collaborate with Quality, Regulatory, Operations, Marketing and Supply Chain to deliver high-quality products while solving complex technical challenges in a

Qualifications

• Bachelor’s degree in Mechanical or Biomedical Engineering or related field.
• 5+ years of product development experience in medical devices.
• Experience with regulated product development, design controls and risk management.
• Proficiency with SolidWorks and GD&T for engineering drawings.
• Ability to create and manage detailed design documentation and DHF deliverables.
• Experience supporting FDA submissions (510(k) or PMA) is a plus.

Responsibilities

• Lead design, development and optimization of Surgical Navigation products from concept to commercialization.
• Translate clinical and user needs into clear product requirements and specifications.
• Coordinate prototyping, testing and analysis to verify product performance and reliability.
• Develop verification and validation plans and reports; manage traceability and documentation.
• Collaborate with Quality, Regulatory, Operations, and Supply Chain to ensure compliant products.

Skills

Technical writing

Analytical

Problem solving

Independent worker

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Biomedical Engineering

Related engineering discipline

Tools

SolidWorks

GD&T

Engineering drawings

Microsoft Office Suite

Job description

Forj Medical is seeking a Product Development Engineer III to lead the design and development of Surgical Navigation products from concept through commercialization. You will transform clinical needs into engineering requirements, drive verification/validation, and maintain design controls to ensure compliant medical devices.

You will collaborate with Quality, Regulatory, Operations, Marketing and Supply Chain to deliver high-quality products while solving complex technical challenges in a