Position Summary
The Program Manager is responsible for leading customer programs from concept through commercialization within a regulated medical device manufacturing environment focused on life sciences and interventional products. This role serves as the primary liaison between customers and internal cross-functional teams, ensuring programs are executed successfully while meeting customer expectations, quality requirements, delivery timelines, and financial objectives.
The Program Manager drives collaboration across Engineering, Manufacturing, Quality, Operations, Supply Chain, Regulatory, R&D, Tooling, and Customer Service to support product development, manufacturing readiness, validation, launch, and transition into production. Programs may involve multiple manufacturing sites, suppliers, and integrated manufacturing technologies working together to support complex medical device solutions.
This role supports a broad range of manufacturing and development capabilities including extrusion, injection molding, dip molding, dip coating, dip blowing, medical device assembly, automation, tooling, secondary operations, and product development activities. The ideal candidate understands how to coordinate cross-functional teams and manufacturing processes to successfully deliver complex medical device programs in a fast-paced CDMO environment.
The successful candidate is a proactive, organized, customer-focused leader with strong communication, collaboration, problem-solving, and project execution skills who can effectively manage multiple priorities while maintaining momentum and accountability throughout the program lifecycle.
Key Responsibilities
Program & Project Leadership
- Lead customer programs through all phases of the product lifecycle including concept, planning, development, validation, commercialization, launch, and transition into production.
- Develop and maintain detailed project plans, schedules, milestones, budgets, resource plans, risk assessments, and mitigation strategies.
- Coordinate and drive cross-functional activities to ensure programs remain on track, within scope, within budget, and aligned to customer expectations.
- Manage multiple concurrent projects and priorities within a dynamic manufacturing environment.
- Lead project reviews, milestone meetings, action tracking, and escalation discussions to maintain program visibility and accountability.
- Drive urgency, ownership, and execution discipline across all functional teams.
- Monitor critical path activities and proactively identify and remove barriers impacting program success.
- Manage engineering changes, scope adjustments, customer requests, and project documentation throughout the program lifecycle.
- Support successful transfer of products into manufacturing operations through effective launch planning, validation coordination, and operational readiness activities.
- Coordinate manufacturing transfers and multi-site program activities when required, including tooling moves, process transfers, validation activities, documentation transfer, and continuity planning.
Customer Relationship Management
- Serve as the primary point of contact for customer communication throughout the program lifecycle.
- Build strong, collaborative customer relationships through responsiveness, transparency, professionalism, and consistent execution.
- Lead customer meetings, business reviews, technical discussions, project updates, and escalation management activities.
- Clearly communicate program status, timelines, risks, mitigation plans, and recovery actions using structured reporting and Red / Yellow / Green project health indicators.
- Translate customer requirements into actionable internal deliverables and align cross-functional teams to support customer objectives.
- Manage customer expectations related to timelines, scope, cost, manufacturability, technical feasibility, and operational constraints.
- Partner with Business Development, Commercial, and Operations teams to support quoting activities, scope definition, customer growth initiatives, and new business opportunities.
- Present program updates and performance metrics to internal leadership teams and customer stakeholders at multiple organizational levels.
Cross-Functional Collaboration & Leadership
- Lead and coordinate cross-functional teams including Manufacturing, Engineering, Quality, Supply Chain, Operations, Regulatory, Tooling, R&D, Maintenance, and Customer Service.
- Foster collaboration and accountability across internal departments, suppliers, external partners, and manufacturing sites.
- Drive alignment between customer objectives, operational capabilities, business priorities, and production readiness.
- Facilitate structured problem-solving discussions and ensure timely decision-making to maintain project momentum.
- Influence and lead effectively within a matrixed organization without direct authority over functional teams.
- Support a culture of teamwork, accountability, customer focus, and continuous improvement.
Technical & Manufacturing Coordination
- Support programs involving a wide range of medical device manufacturing and development technologies including extrusion, injection molding, dip molding, dip coating, dip blowing, assembly, automation, tooling, and related secondary operations.
- Coordinate activities across R&D, product development, manufacturing, validation, and commercialization teams to support complex medical device and interventional product launches.
- Develop working knowledge of manufacturing processes, validation requirements, tooling activities, and operational capabilities to effectively manage timelines, risks, customer expectations, and production readiness.
- Collaborate with technical teams to support manufacturability, scalability, process capability, and successful integration of multiple manufacturing technologies within customer programs.
- Support prototype builds, pilot runs, validation activities, and production launch readiness activities.
Risk Management & Problem Solving
- Identify and proactively manage program risks related to schedule, quality, technical execution, resources, supply chain, validation activities, and customer expectations.
- Develop mitigation strategies, contingency plans, and recovery actions for at-risk projects.
- Lead structured problem-solving activities to resolve issues quickly and effectively while minimizing customer and operational impact.
- Escalate critical issues appropriately while maintaining accountability for driving resolution.
- Anticipate challenges and take proactive action to minimize disruptions to program timelines, financial performance, and customer satisfaction.
- Capture lessons learned and support continuous improvement initiatives across program management and operational processes.
Financial & Operational Management
- Manage project financials including budgets, forecasting, cost tracking, change management, and resource planning.
- Monitor project profitability, operational impact, resource utilization, and overall program financial performance.
- Support alignment between project scope, production capacity, manufacturing readiness, and operational priorities.
- Track and report key performance indicators including schedule adherence, milestone completion, launch readiness, customer satisfaction, and financial performance.
- Maintain accurate project documentation including schedules, meeting summaries, action registers, risk logs, validation tracking, and customer communications.
Regulatory, Quality & Compliance
- Ensure programs comply with FDA regulations, ISO 13485 requirements, internal quality systems, and customer-specific standards.
- Partner with Quality and Regulatory teams to support risk management activities, validation planning, change control, documentation, and audit readiness.
- Support successful completion of verification, validation, and commercialization activities including IQ/OQ/PQ coordination where applicable.
- Ensure proper management of documentation, specifications, quality records, and program deliverables throughout the project lifecycle.
- Support resolution of non-conformances, corrective actions, and customer quality concerns related to assigned programs.
Qualifications
- Bachelor's degree preferred in Business, Project Management, Manufacturing, Life Sciences, Engineering, Operations, or related field; equivalent experience will also be considered.
- 3+ years of program management, project management, customer program management, manufacturing, operations, or related experience within a regulated manufacturing environment preferred.
- Experience within medical device manufacturing, life sciences, interventional products, contract manufacturing, plastics processing, extrusion, injection molding, assembly, or related manufacturing environments strongly preferred.
- Working knowledge of product launch, manufacturing operations, commercialization, validation, and production transfer processes.
- Experience leading customer-facing projects and coordinating cross-functional teams.
- Strong organizational, communication, presentation, and relationship management skills.
- Ability to manage multiple priorities, timelines, and customer commitments in a fast-paced environment.
- Proficiency with project management tools such as Smartsheet, Microsoft Project, or equivalent systems preferred.
- Experience working with ERP systems such as IQMS, Epicor, SAP, Oracle, or similar preferred.
- PMP certification, Lean Manufacturing, or Six Sigma experience is a plus.
Core Competencies
- Customer-focused leadership
- Program execution and accountability
- Cross-functional collaboration
- Executive communication and presentation skills
- Organizational agility and multitasking
- Risk assessment and problem-solving
- Financial and operational awareness
- Project planning and coordination
- Relationship building and stakeholder management
- Decision-making and conflict resolution
- Continuous improvement mindset
- Adaptability in a fast-paced manufacturing environment
Success Measures
- On-time and on-budget program execution
- Successful product launch and commercialization
- Customer satisfaction, retention, and partnership growth
- Effective risk management and issue resolution
- Strong cross-functional team alignment and accountability
- Achievement of operational and financial targets
- Regulatory and quality compliance
- Clear communication and program visibility across stakeholders
Additional Information
- Travel may be required to support customer meetings, supplier visits, manufacturing transfers, program launches, validations, and inter-site collaboration activities.
- This role operates within a fast-paced, highly collaborative medical manufacturing environment requiring flexibility, responsiveness, strong organizational skills, and execution discipline.
Acknowledgement
I have received a copy of this job description, have read and understood it, and will complete all assigned duties and responsibilities. I recognize that the company reserves the right to modify this job description and that I will be informed of any and all modifications prior to their effective date.
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