Senior Project Manager

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.

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.

Total Compensation

$150,000-$165,000