NPI Engineer II - Medical Device Process Innovation

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

Job summary

Resonetics is seeking an NPI Engineer to drive new product introductions from design to clinical, pilot, and commercial production. You will develop manufacturing procedures, tooling, and fixtures while aligning with quality, safety, and cost targets.

Responsibilities include process improvements, documentation, validations, and cross-functional teamwork with Product Development and Quality Engineering. The role emphasizes fast-paced, disciplined execution.

Qualifications

• BS or MS in an engineering discipline or equivalent experience.
• At least 1 year manufacturing/engineering experience.
• Strong communication and deadline management.
• Proficient in SolidWorks and GD&T for tooling/fixtures.

Responsibilities

• Design and develop manufacturing procedures, tooling and fixtures.
• Provide production line support and process improvements.
• Create and update manufacturing documentation and QA records.
• Apply LEAN, Six Sigma, DMAIC for problem solving.
• Participate in validations and risk assessments (IQ/OQ/PQ, PFMEA).
• Support transfer to pilot and commercial production.
• Prepare engineering reports and train staff.

Skills

Strong communication

Analytical skills

Deadline management

Cross-functional collaboration

Written communication

Education

BS or MS in relevant Engineering discipline

Tools

SolidWorks

Job description

Resonetics is seeking an NPI Engineer to drive new product introductions from design to clinical, pilot, and commercial production. You will develop manufacturing procedures, tooling, and fixtures while aligning with quality, safety, and cost targets.

Responsibilities include process improvements, documentation, validations, and cross-functional teamwork with Product Development and Quality Engineering. The role emphasizes fast-paced, disciplined execution.