Senior R&D Production Engineer (CONTRACT)
4900 Bethania Station Road Winston Salem, NC 27105 US
Job Description
Hourly Pay Range - $55.00-85.00/hr DOE Key Responsibilities
- Lead the development and scaling of new products from prototype to mass production, ensuring compliance with industry standards and regulatory requirements.
- Collaborate with cross-functional teams, including R&D, quality, regulatory, and manufacturing, to optimize design for manufacturability (DFM) and ensure efficient production processes.
- Develop and validate manufacturing processes, equipment, and tools to meet quality, cost, and scalability goals.
- Identify, analyze, and solve technical challenges related to production, including design improvements and process enhancements.
- Conduct process capability studies and risk assessments (such as FMEA) to identify and mitigate potential production issues.
- Provide technical guidance to production teams, including training and support for new processes and equipment.
- Implement continuous improvement initiatives to enhance productivity, reduce costs, and improve quality.
- Work closely with suppliers and vendors to specify, source, and qualify materials, components, and production equipment.
- Maintain accurate documentation of processes, experiments, and results to ensure compliance with regulatory and quality management requirements (e.g., ISO 13485, FDA 21 CFR Part 820).
- Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or a related field.
- Minimum of 4-10 years of experience in production engineering or process development, preferably in the medical device industry.
- Strong knowledge of medical device regulations (ISO 13485, FDA QSR).
- Experience in scaling production processes from R&D to high-volume manufacturing.
- Proficiency in statistical analysis, process validation, and risk management tools (DOE, FMEA, SPC).
- Hands-on experience with manufacturing technologies such as injection molding, machining, automation, and assembly.
- Excellent problem-solving skills, with a creative and analytical approach to technical challenges.
- Strong project management skills and the ability to lead and influence cross-functional teams.
- Excellent verbal and written communication skills.
Submit your resume to Julia Yeargan at jyeargan@theresource
Meet Your Recruiter
Jordan Milligan
Jordan is a Direct-Hire Recruiter at The Resource, with experience in all aspects of the recruiting process from sourcing to closing. He's passionate about helping companies find their next great hire, and takes pride in helping candidates advance their careers.
Jordan would love to hear from you if you're looking for a new opportunity or have a job opening at your company that needs to be filled quickly. Be sure to connect with him on LinkedIn too!
Hobby: Playing guitar, Favorite getaway: The Outer Banks, Favorite Childhood Book: Lemony Snicket's "A Series of Unfortunate Events" (as a kid, I read every single book in this series multiple times), Favorite Band: Toto, All-time Favorite Vacation Destination: Barcelona, Spain
