Manufacturing Engineer, Senior

Forj Medical • Arden Hills, MN

158d • $100,000 - $130,000 • Onsite

About The Position

The Senior Manufacturing Engineer works cross-functionally to manage production builds of complex electro-mechanical medical devices across multiple product lines. The role includes new product introduction and transfer, pilot builds, production cell layout, production documentation, issue tracking and resolution, and continuous improvement. The incumbent also coaches and mentors the broader Manufacturing Engineering team.

The position manages production builds and product-line issues, keeps production teams aligned on status, and works directly with customers when technical requests or specialized product needs arise. It partners with development engineering to transfer new products into production and creates, updates, and maintains materials build documentation, assembly and test procedures, part drawings, and engineering change orders.

The Senior Manufacturing Engineer leads continuous-improvement efforts, stays current on medical-device requirements and manufacturing trends, owns quality documentation for assigned product lines, and collaborates with Quality Engineering to address and resolve production-line quality issues.

The role is based in St. Paul or Arden Hills, Minnesota, in an office environment, with occasional travel to nearby locations. Candidates must be authorized to work in the United States. The expected starting salary is $100,000 to $130,000, depending on qualifications. Forj Medical offers health, dental, and vision benefits, 401(k) plans, time-off programs, and potential eligibility for an annual bonus program.

Requirements

• Bachelor’s degree in an engineering, technical, or scientific discipline.
• At least 6 years of manufacturing engineering experience in an electronic-based manufacturing environment.
• Demonstrated experience in regulated environments, such as FDA QSRs and ISO 13485 for medical devices.
• Proficiency with quality-improvement tools and techniques.
• Proficiency in writing and editing production and other technical documents.
• Strong interpersonal communication skills.
• Strong analytical skills and problem-solving ability.
• Ability to work independently and as a team member, and to lead cross-functional teams.
• Proficiency with the Microsoft Office productivity suite.
• Must be authorized to work in the United States.

Nice To Haves

• Master’s degree in a STEM field.
• Leadership experience in operations.
• Engineering experience with medical-device manufacturing.

Responsibilities

• Manage production builds across multiple product lines, maintain issue lists, and drive necessary device improvements and changes.
• Serve as the primary point of contact for production-team communication and alignment on production status.
• Work directly with customers as needed to support technical requests or specialized product needs.
• Coordinate and manage the transfer of new products into production in partnership with development engineering.
• Create, update, and maintain materials build documentation, assembly and test procedures, part drawings, and engineering change orders.
• Develop, implement, and lead continuous-improvement efforts to help the department meet its goals.
• Stay current on medical-device requirements and existing and emerging manufacturing processes and trends.
• Own and execute quality documentation requirements for assigned product lines.
• Partner with Quality Engineering to troubleshoot and resolve production-line quality issues and concerns.
• Coach and mentor the broader Manufacturing Engineering team.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401(k) plans
• Time-off programs
• Potential eligibility for an annual bonus program, depending on individual and organizational performance

What This Job Offers

• Job Type: Full-time
• Career Level: Senior