Senior Research And Development Engineer

The Resource is seeking an experienced Senior R&D Production Engineer to join our client, a leading medical device manufacturing company. This position is responsible for bridging the gap between R&D and production, ensuring a smooth transition and scaling of new products from concept through full-scale manufacturing. The ideal candidate will have strong technical expertise, a passion for innovation, and a proven track record of leading successful production development initiatives in the medical device industry.

Position Type - Contract - 12 months

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).

Qualifications

• 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.