Job Title: Manufacturing Engineering Manager
Position Description: Protingent Staffing has an exciting direct hire Manufacturing Engineering Manager with our client.
Job Description:
- The Manufacturing Engineering Manager leads the Manufacturing Engineering team in the development, management, and continuous improvement of the manufacturing lines, equipment, processes, and training on the production floor.
- As the owner of how manufacturing is done this key role oversees a team of skilled Manufacturing engineers that ensure production is able to meet the growing business demands.
- This leader supports both their technical development, as well as identifies, plans, and guides their work to optimize production efficiency, quality, and consistency.
Job Responsibilities:
- Oversees and leads the creation, maintenance, and continuous improvement of the manufacturing systems (processes, equipment, training, etc.) used to manufacture the medical devices, both for existing and new designs
- Oversees and leads the specification, development, and maintenance of production line test methods, processes, and fixtures; ensures that the approach to testing scales to meet the growing business needs
- Develop, maintain and track capital equipment budget for needed manufacturing investments
- Actively monitors the manufacturing industry for state of the art in these areas to ensure the production environment is robust, efficient, and scalable
- Ensure the team, process, and systems align with applicable regulations (FDA 21 CFR Part 820, ISO 13485, 2017/745/EU Medical Device Regulation); 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 appropriate strategy for in-house versus outsourced calibration; ensures program efficiency, compliance, and scalability.
- Partners with other departments such as 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
- Oversees and leads the Manufacturing Engineering team through the NPI and design transfer processes; ensures that designs and their manufacturing processes are robust and repeatable
- Provides mentorship and guidance to the Manufacturing Engineering team, assisting in their development and strategically growing and diversifying their skillset to best support the success
- Perform other duties as assigned.
Job Qualifications:
- 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 thereof during the engineering development process
- Thorough knowledge of the Manufacturing Engineering discipline as it applies to NPI, including production line setup, test procedure development, and measurement of manufacturing system performance against defined acceptance criteria
- Thorough knowledge of New Product Introduction (NPI) and the design lifecycle, with hands on experience in leading programs through each phase - from engineering development through manufacturing validation, production release, and the ongoing manufacturing support of active designs
- Thorough knowledge of Continuous Improvement processes (i.e. 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/manage a vision and 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 / Experience:
- Bachelor's degree in engineering or equivalent experience
- Typically has greater than seven (7) years of relevant professional or technical engineering management experience of increasing responsibility and difficulty of assignment
- Experience manufacturing regulated equipment. Ideally this experience is in a medical or similar safety-conscious, highly regulated industry.
Job Details:
- Job Type: Direct Hire
- Salary Range: $125-150K.
- Location: Kennewick Washington (Onsite).
About Protingent: Protingent is an
Award-Winning provider of top-tier Engineering and IT talent, trusted by companies at the forefront of innovation - from
Software and Aerospace to
AI, Clean Tech, Medical Devices, and Connected Technologies. We're passionate about making a positive impact by connecting exceptional talent with meaningful opportunities and helping our clients build the future.
Meet Your Recruiter
Sankalp Chivhane