Manufacturing Engineer, Senior

Forj Medical•Arden Hills, MN

22d•$100,000 - $130,000•Onsite

About The Position

Exceptional People. Hard Problems. Meaningful Careers. Big Impact. Nowhere else can you touch as many life-changing medical technologies. At Forj Medical, we work side by side with more than 100 medical device companies from startups to global giants to bring life-enhancing technologies to market. Working with us means solving hard problems with extraordinary people in a collaborative work environment. Join us. 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.

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.
Must be authorized to work in the United States

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.