Manufacturing Engineer, Senior

Job Summary

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.

Key Responsibilities

Production Management & Support

• Product line management: Manage production builds across multiple product lines, actively maintaining the issues list and driving necessary device improvements and changes.
• Team communication: Serve as the primary point of contact to keep the production team aligned and informed on production status.
• Customer interface: Work directly with customers as needed to support technical requests or specialized product needs.

Design Transfer & Documentation Control

• New product transfer: Partner closely with development engineering to coordinate and manage the smooth transfer of new products into production. 
• Documentation lifecycle: Create, update, and maintain core production documentation, including materials build documentation, assembly and test procedures, part drawings, and engineering change orders (ECOs).

Continuous Improvement (CI) & Technical Awareness

• CI initiative leadership: Develop, implement, and lead the team’s CI efforts to ensure the department hits its established CI goals.
• Industry and process trends: Maintain an up-to-date awareness of medical device requirements and stay current on existing and emerging manufacturing processes and trends.

Quality Integration & Compliance

• Quality documentation: Own and execute quality documentation requirements specific to the assigned product lines.
• Quality collaboration: Partner directly with the Quality Engineering team to quickly address, troubleshoot, and resolve any quality issues or concerns that arise on the line. 

Qualifications

Required:

• 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. 

Preferred:

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

Working Conditions

• Must be authorized to work in the United States
• Office environment

Location

• Based in St. Paul or Arden Hills, Minnesota, with occasional travel to other nearby locations

Compensation 

• The expected starting salary for this position is $100,000 to $130,000 depending on qualifications. As part of your overall rewards, we offer a comprehensive benefits program.