Senior Medical Device Program Lead — Cross-Functional Impact

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

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.