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Manufacturing Process Development Manager
3 months ago
We are looking for a Process Development Manager to join our client's growing manufacturing team. The Process Development Manager will lead and support new product and development activities. This individual will be responsible for the design, development, implementation, and control of new and improved manufacturing processes for medical devices.
The role includes providing daily support of products, processes, materials/supplier management, and equipment for new and sustaining products. This individual will manage production builds and ramp-up of verification builds through commercial launch, working with a cross-functional team in a fast-paced and dynamic environment.
Requirements of the Process Development Manager:
- Bachelor's Degree in Engineering, preferably mechanical or biomedical.
- Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies.
- Understanding of medical device design controls/quality systems and product development processes.
- 8+ years of medical device experience in a process/manufacturing engineering role.
- Experience in a regulated environment, preferably medical device.
- Background in adhesive bonding, laser bonding, mechanical assemblies, and electrical assemblies is preferred.
- Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
- Excellent verbal and written communication skills.
- Ability to organize, record, and implement procedures.
- Bonus points for individuals with Six Sigma Certification, CAD software experience (e.g., SolidWorks), and Console Assembly/Electrical Assembly knowledge and/or experience.
Responsibilities of the Process Development Manager:
- Create and implement manufacturing processes for new and current disposable medical devices.
- Work with suppliers globally to understand and define their manufacturing processes, equipment, and tools/fixtures to ensure quality products are delivered.
- Perform characterization, Design of Experiments (DoE), and write/perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
- Create manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents.
- Lead a team of engineers and technicians on business activities for manufacturing.
- Innovate, design, and develop processes, procedures, tooling, and/or automation.
- Train and provide direction to direct reports and manufacturing personnel.
- Drive functional excellence initiatives for product/process and technical development.
- Develop department budget, schedules/forecast, and resources.
- Manage production builds and optimization to meet business needs.
