Sr Program Manager

Professional Employment Group of Colorado; Olathe (KS); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Annual discretionary bonus

Merit increase consideration

Job summary

Unknown Medical Device Company is seeking an experienced Program Manager to lead cross-functional programs from concept through commercialization in a fast-paced, highly regulated environment.

You will own timelines, budgets, and resources for programs ranging from about $1.5M to $4M, coordinating across engineering, software, manufacturing, regulatory, and quality teams while steering Agile/Scrum development cycles.

Qualifications

• 10+ years of program or project management experience in medical device development.
• Strong understanding of medical device product development, QMS, regulatory requirements, documentation, and design controls.
• Track record of leading cross-functional teams through full product lifecycles in regulated environments.
• Experience with Agile/Scrum methodologies.
• Comfort operating in a growing organization where processes are still being built.

Responsibilities

• Lead complex medical device programs from design through development, documentation, regulatory submission, and manufacturing transfer.
• Own program timelines, budgets, resources, and forecasting for initiatives from $1.5M to $4M.
• Serve as central integrator across engineering, software, manufacturing, regulatory, and quality teams.
• Identify risks, gaps, and dependencies and hold teams accountable to commitments.
• Support QMS processes, documentation control, ECOs, and design controls throughout the product lifecycle.
• Partner with PMO, engineering leadership, and systems engineering to improve program execution.
• Participate directly in Agile/Scrum development cycles.

Skills

Program management

Cross-functional leadership

Agile/Scrum

Regulatory understanding

MS Project / project tools

Tools

MS Project

NetSuite

Project Insight

Job description

Our client is a fast-growing medical device company specializing in the design, development, and manufacturing of complex Class II and Class III devices. As a contract design and manufacturing partner, they support the advancement of technologies used in cardiology, oncology, neurology, gene therapy, and other critical therapeutic areas, helping bring life-changing products to patients worldwide.

They are looking for an experienced Program Manager to lead cross-functional programs from concept through commercialization in a hands-on, fast-paced, highly regulated environment.

What You'll Do

• Lead complex medical device programs from design through development, documentation, regulatory submission, and manufacturing transfer
• Own program timelines, budgets, resources, and forecasting for initiatives ranging from approximately $1.5M to $4M
• Serve as the central integrator across engineering, software, manufacturing, regulatory, and quality teams — driving alignment without dictating technical solutions
• Identify risks, gaps, and dependencies early, and hold teams accountable to program commitments
• Support QMS processes, documentation control, ECOs, and design controls throughout the product lifecycle
• Partner closely with the PMO, engineering leadership, and systems engineering to continuously improve program execution
• Participate directly in Agile/Scrum development cycles

What You Bring

• 10+ years of program or project management experience, with meaningful work in medical device development
• Strong understanding of medical device product development, QMS, regulatory requirements, documentation, and design controls
• A track record of leading cross-functional teams through the full product lifecycle in a regulated environment
• Experience with Agile/Scrum methodology
• Comfort operating in a growing organization where processes and infrastructure are still being built
• Working knowledge of tools such as MS Project, NetSuite, Project Insight, or similar
• A leadership style built on accountability, transparency, and technical fluency — you understand engineering tradeoffs without needing to make the technical calls yourself

Why Join

• Work on technology that directly improves patient outcomes across heart failure, cancer, stroke, gene therapy, and more
• Join a company at a stage where your process improvements and leadership will have a direct, visible impact
• Competitive base salary plus annual discretionary bonus and merit increase consideration
• Collaborate directly with PMO and engineering leadership in a high-trust, high-autonomy environment