- Company Name
- Warwick Consulting
- Job Title
- Senior Project Manager-Medical Device
- Job Description
-
Job title
Senior Project Manager – Medical Device
Role Summary
Lead engineering and regulatory teams through software development lifecycle from concept to commercial launch, ensuring compliance, quality, and timely delivery in a regulated medical device environment.
Expactations
• Fully accountable for cross‑functional project execution and alignment of priorities, timelines, and resources.
• Provide strategic guidance, influence stakeholders without formal authority, and maintain rigorous risk and compliance oversight.
Key Responsibilities
- Plan, execute, and close end‑to‑end software product delivery, maintaining integrated project plans and dashboards.
- Facilitate decision‑making across Engineering, UX, Product, Quality, Regulatory, Security, and Commercial groups, surfacing trade‑offs and ensuring clear, data‑driven alignment.
- Manage risk throughout development, maintain FMEAs, hazard analyses, and other ISO 14971 tools, and lead design change impact reviews.
- Oversee development governance: requirements, design, verification/validation, and release readiness reviews.
- Escalate program blockers, risks, and compliance issues proactively, ensuring stakeholders remain informed.
- Continuously improve project management practices, identifying efficiencies and embedding best practices.
- Ensure deliverables meet 21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, and other applicable regulatory standards.
Required Skills
- 5+ years in medical device New Product Development with software focus.
- Deep understanding of design control, risk management, and quality system regulations.
- Proven experience leading cross‑functional teams and managing quality‑related deliverables.
- Strong analytical, documentation, and communication competencies.
- Proficiency with project planning tools, risk assessment frameworks, and regulatory documentation.
Required Education & Certifications
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Software Engineering, or related technical field.
- Familiarity with IEC 62304, ISO 14971, ISO 13485, and 21 CFR 820 regulations.
- Relevant certifications (e.g., PMP, Six Sigma, Certified Quality Engineer) preferred but not mandatory.