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Senior Manufacturing Engineering

$100k - $130k

SPINX Company

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. 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.
Production Management & Support

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.
Customer interface: 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).
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.
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
  • Proficiency working with the Microsoft Office productivity suite.

Master's degree in STEM field
Leadership experience in operations
Engineering experience with medical device manufacturing
Office environment
Paul or Arden Hills, Minnesota, with occasional travel to other nearby locations

Forj Medical provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
We offer health, dental, vision, 401K plans, and time off programs. You may also be eligible to participate in an annual bonus program which depends on various factors, including, individual and organizational performance.

Vacancy posted 1 day ago
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