Senior Staff/Principal Program Manager – IVD Development
Delfi Diagnostics
full-time
Posted on:
Location Type: Hybrid
Location: Palo Alto • California • 🇺🇸 United States
Visit company websiteJob Level
Senior
Tech Stack
PMP
About the role
- Lead and coordinate cross-functional project teams including R&D scientists, regulatory affairs, quality assurance, clinical operations, and engineering stakeholders
- Drive the end-to-end integration of IVD product development, accountable from feasibility through regulatory clearance/approval and market launch
- Collaborate with key technical stakeholders to drive the execution of analytical validation studies
- Implement and maintain PMO best practices, standard operating procedures, and governance frameworks
- Translate business strategy into executable program roadmaps
Requirements
- Bachelor's degree in Life Sciences, Engineering, or related technical field; advanced degree (MS, PhD, or MBA) strongly preferred
- 6-10+ years of experience in IVD or medical device product development, with 3-7+ years in demonstrated cross-functional leadership roles
- Experience managing analytical and clinical validation studies for 2-4+ IVD products across varying complexity levels
- Proven track record of successful regulatory submissions (510(k), PMA, or IVDR) and product launches
- Experience with program management tools like Smartsheet, MS Project, Google Office Suite, Jira
- PMP, PgMP, or equivalent certification preferred
Benefits
- Health insurance
- Professional development
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
IVD product developmentanalytical validation studiesclinical validation studiesregulatory submissions510(k)PMAIVDRprogram management
Soft skills
cross-functional leadershipcollaborationproject managementstrategic planning
Certifications
PMPPgMP