Operations Project Portfolio Manager (Medical Device Industry)
Position Summary
The Operations Project Portfolio Manager oversees the full portfolio of Operations projects within a medical device manufacturing environment, including sustaining engineering, cost‑improvement initiatives, lifecycle management, and New Product Introduction (NPI) programs. This leader ensures all projects comply with medical device regulatory requirements and quality standards while driving operational excellence, predictable execution, and cross‑functional alignment. The role manages a team of Project Managers and collaborates closely with Engineering, Quality, Regulatory, Supply Chain, and Manufacturing.
Key Responsibilities
Portfolio Leadership & Strategy
- Own the Operations project portfolio across sustaining engineering, NPI, quality remediation, product transfers, and process validation initiatives.
- Ensure all projects align with FDA QSR (21 CFR Part 820), ISO 13485, and other applicable global medical device regulations.
- Lead portfolio governance processes, including project intake, prioritization, resource planning, and stage‑gate decision‑making (aligned to Design Control requirements).
- Establish transparent visibility into portfolio health, risks, constraints, and resource needs, enabling timely escalation and decision support.
Project Execution Management
- Ensure all projects follow standardized project management methodologies, including risk management (ISO 14971), DMR/DHF documentation alignment, verification/validation planning, and manufacturing readiness.
- Support Project Managers in resolving escalated issues-technical, quality, regulatory, supplier, or capacity-related.
- Guide teams through process validation (IQ/OQ/PQ), change control, design transfer, and product lifecycle management activities.
- Drive operational readiness for NPIs, ensuring smooth ramp‑up, robust manufacturing processes, and compliant documentation.
Leadership & Team Development
- Lead, mentor, and develop a team of Project Managers who run both sustaining and NPI projects.
- Build a high-performing PMO culture grounded in accountability, continuous improvement, regulatory discipline, and operational excellence.
- Coach Project Managers on stakeholder engagement, risk communication, and cross-functional leadership.
Operational Excellence
- Develop and refine PMO tools, templates, and processes tailored to medical device requirements (Design Controls, CAPA-related projects, validation planning, etc.).
- Track and analyze key KPIs such as on-time delivery, budget performance, compliance milestones, and resource utilization.
- Support continuous improvement and Lean initiatives tied to manufacturing quality, cost, and reliability.
- Implement lessons learned and best practices to improve project predictability and regulatory compliance.
Stakeholder Communication
- Act as the primary point of contact for Operations portfolio updates to leadership, including Quality, Regulatory, Engineering, and Operations executives.
- Prepare and present dashboards, stage-gate reviews, business cases, and risk summaries mapped to regulatory and quality milestones.
- Foster strong collaborative relationships across R&D, Quality, Regulatory Affairs, Supplier Quality Engineering, Supply Chain, and Production.
Qualifications
Required
- Bachelor's degree in Engineering, Operations, Life Sciences, or related technical field.
- 7+ years of project or program management experience in the medical device, pharmaceutical, biotech, or similarly regulated industry.
Preferred
- Master's degree in Engineering, Business, or related field.
- PMP, PgMP, or equivalent project management certification.
- Experience with Class II or Class III medical devices, combination products, or electromechanical systems.
- Lean/Six Sigma certification.
- Experience with electronic Quality Management Systems (eQMS), PLM tools, or ERP/MRP systems.
- Direct experience with FDA Design Controls, ISO 13485, risk management (ISO 14971), and validation methodologies.
- Experience managing both NPI and sustaining engineering portfolios.
- Strong leadership, communication, and organizational skills.
- Demonstrated ability to lead cross-functional teams in a regulated environment.
Competencies
- Strong regulatory and quality system awareness
- Cross-functional leadership in a regulated environment
- Risk and resource management
- Data-driven decision-making
- Excellent communication and executive presentation skills
- Continuous improvement mindset
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
- Employee Stock Purchase Plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
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If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.