Project Manager (SaMD)

Required Skills & Experience

• Bachelor’s degree in Engineering, Computer Science or a related field.
• 8+ years of program or project management experience in medical devices or another regulated industry.
• Hands-on experience managing software programs from requirements through testing and release.
• Experience managing external development partners, such as software developers or technology suppliers.
• Experience leading global or OUS product launches, including international regulatory and market access requirements.
• Experience with medical device software (SaMD), digital surgery, navigation, robotics, imaging or AI-enabled devices preferred.
• Strong knowledge of the software development lifecycle, including Agile, iterative or hybrid development.
• Working knowledge of design controls and quality system requirements (e.g., FDA 21 CFR 820.30, ISO 13485, IEC 62304), including how they apply to partner deliverables.
• Working knowledge of international regulatory, data privacy and cybersecurity requirements (e.g., EU MDR, GDPR) and how they affect launch timing.
• Ability to lead cross-functional teams without direct authority and hold internal and external teams accountable.
• Comfortable working with software and systems engineers and moving between technical detail and leadership updates.
• Spots problems early and brings a plan to fix them, not just the problem.
• Clear, concise written and verbal communication skills.
• Proficiency with program and collaboration tools (e.g., MS Project, Smartsheet, Jira or Azure DevOps, SharePoint).

Job Description

Project ManageThe Senior Project Manager, Digital Surgery runs day-to-day execution on a multi-year digital surgery program. An external partner develops the clinical software, and internal teams build the software and hardware platform it runs on. This role keeps all of it on one plan. The role also leads the program’s expansion outside the U.S., working with global cross-functional teams to launch the product in new markets. It is a hands-on position that requires real experience managing software development in a regulated medical device environment. ment