About
Analog Devices is seeking a hands‑on Senior Project Manager in the development and commercialization of innovative medical device products within our Medical Products Business Unit. This critical role is responsible for end‑to‑end project delivery—from concept through release—ensuring projects are completed on time, within budget, and in compliance with regulatory and quality standards. The ideal candidate brings robust project leadership, a proven track record in regulated product development, and excels at stakeholder management, risk mitigation, and process improvement.
Job Title: Senior Project Manager, Medical Products (P3)
Job Summary
Job Summary: Analog Devices is seeking a hands‑on Senior Project Manager in the development and commercialization of innovative medical device products within our Medical Products Business Unit. This critical role is responsible for end‑to‑end project delivery—from concept through release—ensuring projects are completed on time, within budget, and in compliance with regulatory and quality standards. The ideal candidate brings robust project leadership, a proven track record in regulated product development, and excels at stakeholder management, risk mitigation, and process improvement.
Key Responsibilities
- Lead planning, coordination, and execution of complex medical device development projects (hardware, software, clinical, regulatory, and marketing) from concept to commercialization.
- Develop, manage, and optimize detailed project plans, timelines, budgets, resource allocations, and risk registers.
- Act as the primary point of contact for internal and external stakeholders, including R&D, Quality, Regulatory, Operations, Contract Manufacturers, and external partners.
- Proactively identify, assess, and mitigate project risks; implement creative solutions and corrective actions as needed.
- Facilitate regular project meetings, status updates, and transparent communication of objectives, progress, and changes.
- Exhibit strong problem‑solving skills. Pursues innovative approaches to Time and Cost Analysis, Risk Management and Out of Bounds conditions. Hold teams accountable and proactively identifies risk to the project execution.
- Ensure all project activities adhere to relevant medical device standards (e.g., ISO13485, ISO 14971, IEC 62304), internal QMS, and regulatory requirements (FDA, EU MDR).
- Prepare and present project status reports, KPIs, time/cost analyses, and critical path updates to leadership.
- Track, report, and drive timely closure of activities, issues, risks, and deliverables.
- Foster a collaborative, problem‑solving environment that encourages innovation, accountability, and continuous improvement.
- Mentor and contribute to the project management community within ADI, championing best practices and cross‑team learning.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Business, or a related field (required).
- >5 years of experience in engineering or project management within medical devices, biomedical, diagnostics, or other regulated industries.
- At least 3 years in a Project Management or Portfolio Management role leading cross‑functional teams.
- Proven track record managing complex, cross‑functional product development projects involving hardware, software, clinical, and regulatory workstreams.
- Experience with Design Transfer, NPI, and collaborating with external technology, design, and manufacturing partners.
- Strong understanding of risk management, verification/validation/qualification activities, and regulatory pathways.
- Excellent communication, leadership, and organizational skills; adept at managing executive, engineering, and customer relationships.
- Formal project management training/certification (e.g., PMP, PRINCE2) or equivalent practical experience.
- Proficiency with project management tools (e.g., MS Project, Smartsheet, or similar).
Preferred Qualifications
- Master’s degree a plus.
- Experience managing international projects, distributed teams, or contract manufacturing environments.
- Ability to travel 5-10% as required.
Additional Information
Job Req Type: ExperiencedRequired Travel: Yes, 10% of the timeShift Type: 1st Shift/Days