Manufacturing Transfer & Operations Manager
Location: On-site in Raleigh, NC, with an initial 3-month deployment in Boise, Idaho
An innovative and rapidly growing medical technology organization is preparing to bring a breakthrough product from development into large scale commercial production. This is a rare opportunity to play a foundational leadership role in building manufacturing operations, establishing production excellence, and creating scalable processes that will support significant future growth.
The organization is seeking a hands-on manufacturing leader who thrives in fast paced environments, enjoys solving complex operational challenges, and has successfully guided products from prototype through commercial manufacturing. This position offers exceptional visibility, meaningful ownership, and the opportunity to influence manufacturing strategy from the ground up.
This Role Offers
- Competitive compensation with performance incentives.
- Opportunity to lead commercialization of an innovative medical technology.
- Direct impact on manufacturing strategy, operational excellence, and production scale up.
- High visibility with executive leadership and cross functional stakeholders.
- Long term opportunity to build and optimize U.S. manufacturing operations.
Focus
- Lead the transition of a complex medical device from prototype manufacturing into commercial production.
- Evaluate, stabilize, and improve existing manufacturing processes.
- Drive manufacturing transfer activities to a long-term production operation.
- Develop standardized manufacturing documentation, work instructions, process controls, and quality systems to support scalable production.
- Partner with engineering, quality, supply chain, and contract manufacturing teams to ensure successful commercialization.
- Establish manufacturing metrics, production reporting, inventory controls, and operational visibility across stakeholders.
- Support implementation of automation and continuous improvement initiatives that improve quality, throughput, and repeatability.
- Maintain strong communication with executive leadership while managing multiple external manufacturing partners.
- Help create a manufacturing culture focused on operational discipline, collaboration, and continuous improvement.
Skill Set
- Five or more years of manufacturing leadership experience within regulated industries.
- Demonstrated experience leading manufacturing transfer and commercialization initiatives from development through production.
- Background in regulated manufacturing environments, preferably medical devices. Experience within ISO 13485, or comparable regulated industries such as aerospace, defense, automotive, or ISO 9001 environments is also highly valued.
- Strong knowledge of manufacturing documentation, process validation, manufacturing controls, and production readiness.
- Experience working with contract manufacturers and cross-functional technical teams.
- Excellent communication, organizational, and stakeholder management skills.
- Ability to balance strategic planning with hands on operational execution.
- Strong analytical and problem-solving capabilities with exceptional attention to detail.
Preferred Qualifications
- Experience supporting automation, manufacturing scale up, or new product introduction.
- Experience working in startup or high growth manufacturing organizations.
- Bachelor’s degree in engineering, Manufacturing, Operations, or a related technical discipline.
- Experience supporting products regulated under medical device quality systems.
About Blue Signal:
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