Senior Manufacturing Manager - Medical Device - Hudson, MA

The Senior Manager will oversee day-to-day pilot manufacturing, partner closely with engineering and quality functions, and establish the operational rigor necessary to drive successful product development and manufacturing readiness. The ideal candidate is a strong manufacturing leader who brings technical depth, sound judgment, and the ability to build structure and predictability within a fast-paced medical device environment.

Client Details

My client is a growing Medical Device manufacturer based out of the Hudson, MA area. They are seeking a Senior Manufacturing Manager who will ensure new products can be manufactured consistently, with well-defined processes, robust documentation, and dependable execution, before transitioning to larger-scale production.

Description

The Senior Manufacturing Manager will:

• Lead internal pilot manufacturing operations supporting development, validation, and early production builds
• Ensure disciplined, consistent execution of build schedules with clear accountability
• Partner with Process Engineering to define stable, repeatable manufacturing processes
• Ensure documentation, work instructions, and readiness criteria are complete prior to each build
• Support new product introduction by managing the transition from engineering development into manufacturing
• Collaborate with Quality, Supply Chain, and Engineering to maintain alignment and uphold product quality
• Build, mentor, and manage a team of manufacturing leads, engineers, and operators
• Provide leadership with clear visibility into build performance, risks, and areas for operational improvement

Profile

The Senior Manufacturing Manager should have the following qualifications:

• 8-12+ years of experience in manufacturing or operations (medical device highly preferred)
• Demonstrated experience leading teams in regulated manufacturing environments
• Strong understanding of manufacturing processes, documentation systems, and quality frameworks
• Proven success collaborating across engineering, quality, and operations
• Strong problem-solving capabilities and operational leadership skills
• Experience with new product introduction (NPI) or pilot manufacturing
• Background in catheter manufacturing or other complex medical devices
• Familiarity with ISO 13485 requirements or FDA-regulated manufacturing

Job Offer

Competitive compensation

Paid time off

Health benefits

401k with company match

Great company culture with room for career growth!

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