• Lead new product introductions (NPI) and support the scale-up of manufacturing processes.
• Take ownership of tooling and plastic molding, ensuring robust verification and validation of components to support repeatable production.
• Manage global supply chain operations including procurement, supplier performance, inventory, and logistics.
• Oversee validation of new equipment, including documentation in line with quality and regulatory requirements.
• Ensure compliance with ISO 13485 and support the creation of regulatory documentation as needed.
• Coordinate production, inventory control, and distribution planning.
• Manage change control processes (ECRs/ECNs), maintain technical documentation, and ensure quality compliance.
• Work closely with suppliers to reduce lead times and improve operational efficiency.
• Collaborate with Sales, Marketing, and Finance to support product launches, customer audits, and cross-functional initiatives.
• Provide regular updates on operational KPIs and project performance.

 
What You Bring

• A degree in Engineering, Supply Chain, Business, or a related field.
• 5+ years’ experience in operations, process engineering, or supply chain management—ideally in a regulated industry.
• Proven experience in tooling, plastic moulding, and hands-on process development.
• Strong knowledge of manufacturing, logistics, and inventory systems.
• Experience with ERP systems, Excel (PivotTables), MS Project, and other planning tools.
• Strong communication, collaboration, and problem-solving skills.
• Comfortable working in a fast-paced, evolving environment.
• Willingness to travel to engage with suppliers and partners as needed.

 
Bonus Points For

• Familiarity with medical device regulations and documentation.
• Experience with Lean, Six Sigma, or Kaizen continuous improvement methodologies.
• Working knowledge of ISO 13485 and validation protocols in a regulated environment.

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