Manufacturing Engineer, Senior

Forj Medical • Saint Paul, MN

21d • Onsite

About The Position

The Senior Manufacturing Engineer works cross-functionally to manage the production build of complex electro-mechanical medical devices in multiple product lines. The responsibilities of this position include new product introduction, pilot builds, production cell layout, production documentation, issue tracking and resolution, and continuous improvement. In addition, the incumbent coaches and mentors the broader Manufacturing Engineering team.

Requirements

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

Nice To Haves

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

Responsibilities

• Manage production builds across multiple product lines, actively maintaining the issues list and driving necessary device improvements and changes.
• Serve as the primary point of contact to keep the production team aligned and informed on production status.
• Work directly with customers as needed to support technical requests or specialized product needs.
• Partner closely with development engineering to coordinate and manage the smooth transfer of new products into production.
• Create, update, and maintain core production documentation, including materials build documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).
• Develop, implement, and lead the team’s CI efforts to ensure the department hits its established CI goals.
• Maintain an up-to-date awareness of medical device requirements and stay current on existing and emerging manufacturing processes and trends.
• Own and execute quality documentation requirements specific to the assigned product lines.
• Partner directly with the Quality Engineering team to quickly address, troubleshoot, and resolve any quality issues or concerns that arise on the line.

What This Job Offers

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