NPI Engineer II: Medical Device Process Innovator

Resonetics; Westborough (MA); On-site; USD 65,000 - 94,000; Full time

Job summary

Resonetics is seeking an NPI Engineer to translate early designs into scalable manufacturing for medical devices. You will collaborate with Product Development and Quality teams to implement new technologies and ensure smooth transfers to pilot and commercial production.

Responsibilities include designing procedures, enabling process improvements, and contributing to validations and risk assessments. Strong SolidWorks, GD&T, and writing skills are required.

Qualifications

• BS or MS in relevant engineering discipline or equivalent experience (Required).
• Minimum of 1 year experience in a manufacturing environment in an engineering role.
• Strong communication skills and ability to provide project status.
• Demonstrated work ethic and ability to meet deadlines.
• Strong analytical skills with ability to process data.
• Familiarity with statistical analyses (process capability, regression, DOE).
• Proficient in SolidWorks for tooling/fixture design; GD&T and technical drawings.

Responsibilities

• Design and develop manufacturing procedures, tooling, and fixtures to meet demand while promoting quality and safety.
• Provide production line support, implement process improvements, troubleshoot equipment, assist operators.
• Create and modify manufacturing process documentation and ensure it follows QMS policies.
• Apply LEAN, Six Sigma, DMAIC for problem solving and continuous improvement.
• Support development and release of new products and processes per specifications.
• Participate in validations (IQ/OQ/PQ/MVP/TMV) and risk assessments (PFMEA).
• Drive process improvement to recommend scalable equipment and processes.
• Prepare engineering reports and communicate results to the team.
• Create process documentation and conduct training as needed.

Skills

Communication skills

Analytical skills

SolidWorks

GD&T

Problem solving

Cross functional collaboration

Technical writing

Education

BS or MS in engineering

Tools

SolidWorks

Job description

Resonetics is seeking an NPI Engineer to translate early designs into scalable manufacturing for medical devices. You will collaborate with Product Development and Quality teams to implement new technologies and ensure smooth transfers to pilot and commercial production.

Responsibilities include designing procedures, enabling process improvements, and contributing to validations and risk assessments. Strong SolidWorks, GD&T, and writing skills are required.