Sr. Project Manager

Posted: 26/05/2026

Location:

Minneapolis, Minnesota, United States Salary: $140000 - $160000 Job type:
Permanent

Senior Project Manager

About the Role

Seeking a Senior Project Manager to lead and manage complex new product development initiatives in the medical device sector. This role sits at the intersection of engineering depth and customer ownership - the PM is the voice of the customer internally and the face of the company externally. Programs are currently in or approaching design verification (DV), spanning catheter systems, delivery platforms, and energy delivery consoles.

The right candidate steps in and drives - this is not a role with junior support or an extended ramp period.

Duties and Responsibilities

• Lead and manage 1-3 concurrent medical device development programs from concept through commercialization, owning both the customer relationship and internal project execution.
• Develop and maintain comprehensive project plans including timelines, budgets, resource allocation, and risk management strategies.
• Serve as the primary customer interface - understanding customer needs, managing expectations, communicating status, and acting as the customer's internal advocate.
• Set priorities and vision for cross-functional core project teams, coordinating across R&D, electrical, software, quality, and operations as the program requires.
• Ensure compliance with FDA regulations and the company's quality system throughout the development process; understand and manage how regulatory requirements impact project processes.
• Identify and mitigate project risks proactively - surface problems early, mobilize resources to resolve them, and step in directly when needed to keep programs on track.
• Operate within and contribute to a maturing PMO framework currently being built out across the organization.
• Conduct project reviews and apply lessons learned to drive continuous improvement across the portfolio.
• Support business development by providing informed assessments of project feasibility, timeline impacts, and resource requirements.

Qualifications

Required

• Medical device development experience is essential - candidates must have worked within the FDA regulatory framework and understand how regulations shape development processes. Experience in other highly regulated industries (aerospace, DoD) may be considered on a case-by-case basis.
• Minimum 7 years of combined experience: 3-5 years of hands-on engineering work (manufacturing, R&D, electrical, process development, quality, or regulatory) followed by 2-4 years of project management experience.
• Demonstrated ability to lead cross-functional project teams and own programs end-to-end, with direct accountability for outcomes.
• Experience interfacing directly with customers in a project ownership capacity.
• Strong communication, interpersonal, and influencing skills - able to align stakeholders at all levels without formal authority.
• Comfortable managing multiple projects simultaneously while maintaining attention to detail.

Preferred

• Prior CDMO experience is a meaningful differentiator - candidates who have already navigated the pace and complexity of contract development tend to adapt more quickly.
• Familiarity with 510(k) submission processes and regulatory milestones; candidates do not need to have filed independently, but should understand the submission landscape.
• PMP certification is not required and will not be weighted heavily - practical PM experience and engineering depth matter far more.
• Bachelor's degree in Engineering or a related field; advanced degrees are not prioritized over demonstrated experience.

What Success Looks Like

The PMs who thrive here are the ones who identify problems early and drive them to resolution - whether that means finding the right person to solve it or solving it themselves.

Apply Now