Sr. Operations Project Portfolio Manager

Largo FL

The Sr. 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 leads a team of Project Managers and is responsible for portfolio governance resource planning prioritization and execution of strategic Operations initiatives. Working closely with Engineering Quality Regulatory Supply Chain Manufacturing and R&D leadership this position provides visibility into portfolio performance drives alignment to business objectives and supports executive decision-making regarding project investments resources and priorities.

• Own the Operations project portfolio across sustaining engineering NPI quality remediation product transfers and process validation initiatives.
• Ensure 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.
• Establish transparent visibility into portfolio health risks constraints and resource needs enabling timely escalation and decision support.
• Partner with Operations leadership to align portfolio priorities and resource allocation with business objectives and operational goals.
• Drive portfolio reviews and strategic planning processes to ensure resources are focused on the highest-value initiatives.

• 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 including technical quality regulatory supplier and capacity-related challenges.
• 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.
• Provide oversight and support for highly complex cross-functional projects that significantly impact operational performance compliance quality or business results.

• Lead mentor and develop a team of Project Managers who run 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.
• Establish operational objectives priorities and work plans for the project management organization.
• Support talent development succession planning and capability building within the PMO function.

• Develop and refine PMO tools templates and processes tailored to medical device requirements.
• 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.
• Drive adoption of standardized project governance reporting and portfolio management processes across Operations.

• Lead portfolio resource planning and capacity management activities to ensure effective allocation of project resources.
• Monitor project portfolio budgets and support investment planning and prioritization decisions.
• Evaluate business cases project benefits risks and resource requirements to support decision-making by Operations leadership.
• Provide regular analysis of portfolio performance resource utilization and project execution trends.

• 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.
• Influence stakeholders across multiple functions to achieve alignment on priorities resources timelines and project execution strategies.
• Present portfolio performance resource needs and strategic recommendations to senior leadership.

• Bachelors degree in Engineering Operations Life Sciences Business or related technical field.
• 8 years of project program or portfolio management experience in the medical device pharmaceutical biotech or similarly regulated industry.
• Experience leading complex cross-functional initiatives in a regulated environment.
• Prior leadership experience managing Project Managers program managers or equivalent project teams 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.
• Direct experience with FDA Design Controls ISO 13485 risk management (ISO 14971) and validation methodologies.
• Lean/Six Sigma certification.
• Experience with electronic Quality Management Systems (eQMS) PLM tools or ERP/MRP systems.
• Experience managing both NPI and sustaining engineering portfolios.

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 option #5.