Mechanical Engineering Manager — Medical Devices Leader

Forj Medical; Saint Paul (MN); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Health insurance

401K plan

Paid time off

Job summary

Forj Medical in Minnesota seeks a Mechanical Engineering Manager to build and lead a high‑performing team focused on design, development, and commercialization of medical devices.

You will guide engineers and designers, ensure regulatory compliance (FDA QSR, ISO 13485), and drive continuous improvement across programs from concept to launch.

This role requires a strong technical leader with 10+ years in regulated environments, plus mentoring, budgeting, and cross‑functional collaboration.

Qualifications

• Bachelor of Science in Mechanical Engineering or related field.
• Minimum 10 years of engineering experience including at least 2 years in engineering leadership in medical device development.
• Demonstrated success leading technical teams in a regulated environment.
• Strong knowledge of mechanical design, product development, prototyping, manufacturing processes, and product testing.
• Experience with FDA QSR, ISO 13485, and/or ISO 9001 standards.

Responsibilities

• Lead, mentor, and develop a multidisciplinary team supporting cross-functional product development programs.
• Foster a culture of innovation, accountability, collaboration, and continuous improvement.
• Develop workforce planning, resource forecasts, and organizational strategies to support business objectives.
• Partner with Program Management and Operations to allocate resources and ensure program success.
• Oversee laboratories, equipment, and development support services.

Skills

Engineering leadership

Team development

Regulatory knowledge

Mechanical design

Project management

Communication

Prototyping

Education

Bachelor of Science in Mechanical Engineering

Job description

Forj Medical in Minnesota seeks a Mechanical Engineering Manager to build and lead a high‑performing team focused on design, development, and commercialization of medical devices.

You will guide engineers and designers, ensure regulatory compliance (FDA QSR, ISO 13485), and drive continuous improvement across programs from concept to launch.

This role requires a strong technical leader with 10+ years in regulated environments, plus mentoring, budgeting, and cross‑functional collaboration.