Senior Director​/VP of Manufacturing

The Senior Director / Vice President of Manufacturing is a senior leadership role primarily responsible for overseeing, optimizing, and scaling all manufacturing-related functions. This role has a strong hands‑on focus on manufacturing execution, production planning, sustaining engineering, and supply chain readiness within a regulated medical device environment.

The position ensures manufacturing excellence across quality, cost, delivery, and compliance, while partnering with R&D and Quality to support product development, transfer, and commercialization. Success is defined by building scalable manufacturing processes, improving efficiency, and ensuring consistent, compliant production to support business growth.

• Provide executive leadership and direct oversight of all manufacturing operations, including production, assembly, kitting, purchasing, supplier management, and sustaining engineering.
• Develop and execute a manufacturing strategy aligned with company growth, product roadmap, and commercialization timelines.
• Own manufacturing readiness for new product introductions (NPI), including design transfer, process validation, equipment qualification, and scale‑up.
• Drive manufacturing efficiency, yield, cost reduction, and capacity planning through Lean manufacturing, Six Sigma, and continuous improvement initiatives.
• Establish and maintain best practices for production planning, inventory management, component sourcing, and supplier performance.
• Oversee sustaining engineering activities, including manufacturing engineering, equipment maintenance and qualification, root cause investigations, and product failure analysis.
• Partner closely with R&D to ensure manufacturability, process robustness, and smooth transition from development to production.
• Collaborate with Quality Assurance to define, implement, and maintain manufacturing and production procedures compliant with FDA, ISO 13485, MDD/MDR, and other applicable international regulations.
• Ensure manufacturing operations consistently meet quality, regulatory, and documentation requirements.
• Lead, mentor, and develop manufacturing managers and staff, fostering accountability, engagement, and a culture of safety, quality, and continuous improvement.
• Establish manufacturing KPIs (e.g., throughput, yield, scrap, on‑time delivery, cost) and use data‑driven insights to drive performance improvements.
• Manage multiple manufacturing projects and priorities through clear policies, procedures, and systems.
• Serve as the primary manufacturing interface with suppliers, contract manufacturers, auditors, and regulatory agencies, as needed.

May require domestic and international (including China) travel.

• 12–15+ years of progressive manufacturing leadership experience, preferably within the medical device industry. Final leveling (Senior Director or Vice President) will be determined based on experience, scope, and organizational needs.
• At least 7+ years of progressive responsibility leading manufacturing, production, and sustaining engineering teams in a regulated environment.
• Deep working knowledge of FDA, ISO 13485, MDD/MDR, and international manufacturing and quality requirements.
• Proven experience leading manufacturing scale‑up, process validation, and product commercialization.
• Strong background in Lean manufacturing, Six Sigma, and driving measurable improvements in cost, quality, yield, and delivery.
• Demonstrated success in manufacturing transfer from R&D to production and supporting ongoing sustaining activities.
• Experience managing suppliers, component sourcing, and external manufacturing partners.
• Ability to work effectively with cross‑functional teams, including R&D, Quality, Regulatory, and Supply Chain, to resolve manufacturing and production challenges.
• Excellent verbal, written, and interpersonal communication skills, with the ability to influence across technical and leadership teams.
• Advanced proficiency in Microsoft Word, Excel, PowerPoint and Net Suite.

Bachelor’s degree in Operations, Engineering, Manufacturing, or a related field, or equivalent experience required. Advanced degree…