Supplier Engineering - Project Manager - Axelon Services Corporation

Position: Supplier Engineering - Project Manager Consultant (Hybrid)
Location: Plymouth, MN or Colorado Springs, CO

High-Level Must-Haves:

1. Engineering Degree with experience in Manufacturing Engineering or Project Management (Quality experience is advantageous but not primary).
2. Hands-on experience with Process Validation IQ, OQ, and PQ.
3. Global Project Management experience in Medical Devices (preferably in companies like Healthcare, Client, Stryker, Boston Sci, Baxter, or similar).
4. Minimum 1-year role stability in one position.

Job Description:

• Lead Supplier Qualification and Part Qualification for Vasper Products.
• Monitor Supplier Quality Performance for Vasper Products, develop Quality processes related to Supplier Quality Control, and assist in supplier audits and qualification.
• Drive supplier improvement through SQIP (Supplier Quality Improvement Plans).
• Experience in Electro-mechanical and Stent Commodity.
• Responsible for ensuring compliance with regulatory standards.
• Provide routine department status updates to management.

Required Qualifications:

• Bachelor s degree in Engineering (Electrical or Mechanical).
• Minimum 7 years experience, with medical device experience required.
• Minimum three years of GMP manufacturing experience required.
• Proficiency in technical innovation, technical leadership, mechanical and/or chemical engineering, fluids engineering, and cellular biology.
• Ability to troubleshoot mechanical and electronic equipment.
• Understanding of and adherence to GMP practices and FDA regulations.
• Willingness to travel 25-50%, with some international travel possible.
• Ability to work in a general labor environment, including using personal protective equipment and occasional lifting.