Manufacturing Engineering Manager

Manufacturing Engineering Manager

Protingent Staffing has an exciting direct hire Manufacturing Engineering Manager position with our client.

The Manufacturing Engineering Manager leads the manufacturing engineering team in the development, management, and continuous improvement of manufacturing lines, equipment, processes, and training on the production floor. As the owner of manufacturing execution, this key role oversees a team of skilled engineers to ensure production meets growing business demands. The leader supports technical development and guides work to optimize production efficiency, quality, and consistency.

• Oversees and leads the creation, maintenance, and continuous improvement of the manufacturing systems (processes, equipment, training, etc.) used to manufacture medical devices, for both existing and new designs.
• Oversees and leads the specification, development, and maintenance of production line test methods, processes, and fixtures; ensures testing scales to meet growing business needs.
• Develops, maintains, and tracks capital equipment budget for necessary manufacturing investments.
• Actively monitors the manufacturing industry for state‑of‑the‑art developments to keep the production environment robust, efficient, and scalable.
• Ensures team, process, and systems align with applicable regulations (FDA 21 CFR Part 820, ISO
  13485, 2017/745/EU Medical Device Regulation) and supports internal and external audits from FDA and notified bodies.
• Oversees and leads the development and continuous improvement of the equipment calibration program, defining the strategy for in‑house versus outsourced calibration to ensure program efficiency, compliance, and scalability.
• Partners with R&D, Supplier Quality, IT, Production, Regulatory Affairs, and Quality Assurance to ensure smooth design transfers and efficient day‑to‑day operation of the production environment.
• Guides the Manufacturing Engineering team through NPI and design transfer processes; ensures designs and their manufacturing processes are robust and repeatable.
• Provides mentorship and guidance to the team, assisting in their development and strategically growing and diversifying skill sets to support success.
• Performs other duties as assigned.

• Comprehensive knowledge of Process Engineering and Optimization to improve efficiency, utilization, throughput, and yield.
• Comprehensive knowledge of the device manufacturing environment and problem solving within its unique technical, regulatory, and operational challenges.
• Thorough knowledge and experience with change control processes and activities.
• Thorough knowledge of design‑for‑manufacture concepts and practical application therein during engineering development.
• Thorough knowledge of the Manufacturing Engineering discipline as it applies to NPI, including production line set‑up, test procedure development, and measurement of manufacturing system performance against defined acceptance criteria.
• Thorough knowledge of NPI and the design lifecycle, with hands‑on experience in leading programs through each phase – from engineering development through manufacturing validation, production release, and ongoing support of active designs.
• Thorough knowledge of Continuous Improvement processes (Lean Manufacturing, Six Sigma, Kaizen, 5S, etc.).
• Thorough knowledge of Automation and Technology Integration; experience with practical applications of technologies and smart manufacturing integration to increase quality and reduce rework.
• Demonstrated ability to create and manage a vision, think strategically, plan and organize, innovate, analyze complex data and situations, and exercise sound judgment; able to communicate that vision, motivate and lead employees, and collaborate with other teams.
• Demonstrated ability to assess and clearly communicate risk with appropriate urgency, ensuring manufacturing programs stay on schedule; brings a strategic perspective that enables effective contingency planning, cross‑functional alignment, and consistent follow‑through on execution.
• Education:
  
  Bachelor’s degree in engineering or equivalent experience.
• Experience:
  
  Greater than seven (7) years of relevant professional or technical engineering management experience of increasing responsibility.
• Experience manufacturing regulated equipment, ideally in a medical or similar safety‑conscious, highly regulated industry.

• Job Type: Direct Hire
• Salary Range: $125,000–$150,000
• Location:
  
  Kennewick, Washington (onsite)