Operations Project Portfolio Manager

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 costimprovement 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 crossfunctional 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 stagegate decisionmaking (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 issuestechnical 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 rampup 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

• Bachelors 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

• Masters 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

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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 option #5.