Job Description
Job Description
Job Title: Program Manager – Manufacturing Operations (Regulated Environment)
Job Description
The Program Manager will lead production-focused programs within a regulated manufacturing environment, with a particular emphasis on medical device operations. This role oversees project scheduling, budgeting, and cross-functional coordination to ensure production activities remain on track and aligned with customer commitments. The Program Manager partners closely with manufacturing, supply chain, production, quality, engineering, and leadership teams to develop and manage project schedules, staffing plans, and budgets while maintaining compliance with regulatory and quality standards. This position offers significant visibility and direct impact on manufacturing execution, operational performance, and customer satisfaction.
Responsibilities
- Develop, own, and maintain detailed manufacturing project schedules that align production activities with customer delivery expectations.
- Coordinate production planning and scheduling across manufacturing, supply chain, production, and quality teams to ensure timely execution of customer programs.
- Build and manage program budgets, including forecasting, cost tracking, and variance analysis, and provide regular financial updates to leadership.
- Monitor program performance against schedule and budget, identify risks and issues, and implement mitigation plans to keep production on track.
- Support manufacturing operations by partnering with production supervisors, manufacturing engineers, inspection teams, and operations staff to enable controlled builds and ongoing production.
- Ensure all programs adhere to applicable quality systems, regulatory requirements, and manufacturing standards associated with medical device production.
- Collaborate with supply chain and procurement teams to align material availability, capacity planning, and resource allocation with production schedules.
- Coordinate cross-functional communication and alignment with operations, engineering, supply chain, and quality teams to drive successful project execution.
- Provide program status updates and performance reports to executive leadership and customer stakeholders, including participation in client-facing reviews.
- Support customer manufacturing programs by coordinating internal resources, managing dependencies, and escalating constraints that may impact delivery timelines.
- Contribute to production planning decisions, including staffing plans and resource allocation, to balance operational priorities and business objectives.
- Participate in or lead Quarterly Business Review presentations and other formal program reviews as needed.
- Support New Product Introduction (NPI) programs by integrating new products into existing manufacturing schedules and processes within the regulated environment.
- Identify opportunities to improve scheduling, budgeting, and operational planning processes and bring fresh perspective to ongoing manufacturing programs.
Essential Skills
- Bachelor's degree or equivalent professional experience.
- Minimum 5 years of professional experience in a relevant field.
- Minimum 1–2 years of direct ownership of project scheduling responsibilities.
- Minimum 1–2 years of experience managing project budgets, forecasts, or cost tracking.
- Proven experience supporting manufacturing operations or production environments.
- Demonstrated experience working cross-functionally with operations, production, engineering, and supply chain teams.
- Hands-on experience using scheduling, production planning, ERP, or MRP systems.
- Experience working in a regulated industry environment, such as medical devices, pharmaceuticals, or similar regulated sectors.
- Strong project management skills, including coordination, prioritization, and risk management.
- Ability to interpret and act on production schedules, staffing plans, and operational data.
- Excellent communication skills, with the ability to collaborate effectively across multiple departments and with leadership and customer stakeholders.
Additional Skills & Qualifications
- Experience in medical device manufacturing.
- Experience working in an FDA-regulated environment.
- Familiarity with ISO standards relevant to manufacturing and quality systems.
- Good Manufacturing Practice (GMP) experience.
- Experience with contract manufacturing environments.
- Production planning experience in a regulated manufacturing setting.
- Supply chain coordination experience, including alignment of materials and capacity with production schedules.