Job Description

Senior Project Manager

Location: St. Louis Park, MN (Hybrid) 

Job Summary: 
We are seeking an experienced Senior Project Manager to lead product lifecycle and continuous improvement projects for active implantable medical devices (AIMDs).  This role will be responsible for maintaining business continuity, improving existing designs, and managing product lifecycle changes.  The ideal candidate will proactively lead cross-functional teams to identify, plan, and execute business critical projects. 

Responsibilities: 

• Be the translator between business and technical to lead the identification of risks and opportunities and deliver solutions. 
• Drive planning and execution of R&D projects including design transfer, product upgrades, material obsolescence, cost-reduction initiatives, corrective actions, and geography expansions while ensuring project milestones are met within scope, schedule, and budget. 
• Lead cross-functional teams including R&D, Quality, Regulatory, Operations, and Contract Design and Manufacturing Organizations. 
• Drive compliance with medical device standards and regulations, including ISO 13485, ISO 14971, IEC 62304, and IEC 60601.  
• Provide regular status updates and lead project reviews. 
• Ability to travel domestically and internationally up to 25%. 

Required Qualifications: 

• Bachelor’s degree in engineering or related field.  
• 7+ years of experience in project management and/or engineering for Class II/III medical devices.  
• Proven track record in medical device project management, including product launch through end of life.  
• Proven ability to influence both internal and external team members and leadership. 
• Strong knowledge of regulatory requirements for medical devices and experience with design controls, manufacturing process development, and risk management.  

Preferred Qualifications: 

• MBA or master’s degree in engineering or related field. 
• Experience with active implantable medical devices (e.g., neurostimulators, pacemakers, defibrillators, cochlear implants, or similar) 
• Proficient in current, best-practice project management methodologies and tools.  
• Previous participation in regulatory audits. 

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