Contract Manufacturing Product Leader (CM Product Leader) who will also function as the CM Manager for the assigned subcontracted manufacturing partners. The role acts as the primary interface between Arineta and the Contract Manufacturers (CM), ensuring seamless execution of production, adherence to quality standards, efficient management of costs and timelines, and continuous improvement of manufacturing processes. Driving successful collaboration and operational excellence at the CMs site.
The CM Product Leader is responsible for the full lifecycle management of the contract manufacturing relationship, encompassing strategic planning, execution, continuous improvement, and technical leadership at the CM site. This includes, but is not limited to:
Manage, negotiate, and oversee manufacturing contracts, ensuring favorable terms, price stability, capacity, and continuous improvement (CI) strategies.
Implement contracts that drive compliance for a safe and reliable supply, including standard reporting and long-term supply strategies.
Negotiate and manage strategic supply and service agreements with CMs.
Apply advanced negotiation techniques to optimize cost, capital, capability, capacity, quality, and CI (including Engineering Change Orders – ECOs).
Coordinate with contract manufacturers to ensure production schedules are met.
Set periodic (Weekly/Monthly) status and business reviews with each manufacturer/supplier, including data driven monitors & KPI’s to assess the supplier performance.
Monitor manufacturing processes to ensure adherence to quality standards.
Resolve production issues or bottlenecks.
Collaborate with Supply Chain and logistics teams to ensure seamless material flow, inventory management, on time delivery from manufacturers to Arineta – meet OTIF, Inventory, Quality KPI’s.
Align with demand planning and communicate rolling forecasts to manufacturers.
Monitor production timelines, quality, and costs, ensuring adherence to specifications and project milestones.
Proactively manage CM execution and planning to support mid-to-high volume manufacturing, including direct order fulfilment and customer commit dates.
Manage projects from concept to delivery, partnering with internal and external resources, managing budgets, timelines, and scope.
Lead key manufacturing projects, new product introductions, and facility rationalization.
Ensure specifications are established prior to production and all parameters are achieved during qualification, verification, and commercialization.
Collaborate with manufacturing engineering and program managers to prepare product work scopes, estimate shop visit costs and lead times, and maintain accurate MRP data and Bill of Materials (BOM).
Expedite orders to meet production schedules and collaborate with logistics for smooth customs and receiving processes.
Verify material conformity to product configuration and support the product accumulation process.
Monitor manufacturing processes to ensure adherence to quality standards.
Resolve production issues or bottlenecks.
Collaborate with Supply Chain and logistics teams to ensure seamless material flow, inventory management, on time delivery from manufacturers to Arineta – meet OTIF, Inventory, Quality KPI’s.
Align with demand planning and communicate rolling forecasts to manufacturers.
Monitor production timelines, quality, and costs, ensuring adherence to specifications and project milestones.
Proactively manage CM execution and planning to support mid-to-high volume manufacturing, including direct order fulfilment and customer commit dates.
Manage projects from concept to delivery, partnering with internal and external resources, managing budgets, timelines, and scope.
Lead key manufacturing projects, new product introductions, and facility rationalization.
Ensure specifications are established prior to production and all parameters are achieved during qualification, verification, and commercialization.
Collaborate with manufacturing engineering and program managers to prepare product work scopes, estimate shop visit costs and lead times, and maintain accurate MRP data and Bill of Materials (BOM).
Expedite orders to meet production schedules and collaborate with logistics for smooth customs and receiving processes.
Verify material conformity to product configuration and support the product accumulation process.
Skills:
Excellent analytical and problem-solving skills, with a data-driven approach to continuous improvement.
Demonstrated leadership and communication skills, ability to motivate and collaborate effectively.
Education:
Bachelor’s degree in Mechanical Engineering or a related field and MBA required.
Relevant Experience:
Minimum 4 years of experience in manufacturing of medical devices.
Proven success in project planning, resource management, and cross-functional collaboration.
Strong initiative, critical thinking, and a willingness to take on new challenges.
Proven expertise in process validation (PV) and test method validation (TMV) methodologies.
Strong understanding of Quality Management Systems (QMS) and regulatory requirements for medical devices.
Direct experience with tech transfer, validation, and commercial-scale production in a CM environment.
Advantage Experience:
Experience with strategic sourcing, vendor management, and contract negotiation.
Demonstrated business acumen and strong attention to detail.
Subordinate to:
Director of Supply Chain (Primary), Director of Engineering (Secondary on Technical Matters)