NPI Engineer II

Resonetics • Westborough, MA

4d • $65,000 - $94,000

About The Position

The NPI Engineer is a key member of the team responsible for developing advanced medical device products and manufacturing capabilities from early-stage design through market introduction and launch. Working with Product Development and Quality Engineering, the engineer implements new technologies and processes and supports timely transfer to clinical, pilot-line, and commercial production while meeting safety, quality, delivery, cost, and productivity goals.

The role develops, selects, and optimizes component and assembly manufacturing systems based on demand, location, and quality requirements. It also contributes to selecting, vetting, and coordinating external suppliers. As programs move into commercial manufacturing, the NPI Engineer serves as a technical liaison and transfer-team member, helping train production resources.

Requirements

• Bachelor’s or master’s degree in a relevant engineering discipline, or equivalent experience.
• At least 1 year of experience in a manufacturing environment in an engineering role.
• Strong communication skills, including comfort providing project-status updates at the team level.
• Demonstrated work ethic and understanding of deadline management.
• Strong analytical skills and ability to process operational or technical data.
• Familiarity with conventional statistical analyses, including process capability, equivalence studies, regression, ANOVA, and DOE.
• Proficiency in SolidWorks or equivalent for tooling and fixture design; knowledge of GD&T and technical drawing generation.
• Excellent writing skills, including the ability to write detailed reports, comprehensive manufacturing procedures, and validation reports or protocols.
• Training and/or experience in formal problem-solving techniques such as cause-and-effect analysis and 5 Why’s.
• Effective interpersonal skills and ability to work with a culturally diverse employee population.
• Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.
• Must already be legally authorized to work in the United States without visa sponsorship now or in the future.

Nice To Haves

• Experience with Lean Six Sigma methodology and DMAIC principles.
• Experience with catheter-processing equipment, including hot boxes, laminators, split die bonders, and tipping machines.
• Experience working in a medical device or regulated environment.

Responsibilities

• Design and develop manufacturing procedures, tooling, and fixtures to meet customer demand while promoting product quality, process efficiency, and operator safety.
• Support production lines by implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
• Generate and modify manufacturing process documentation, ensuring processes and documentation comply with Resonetics’ Quality Management System policies and procedures.
• Apply LEAN, Six Sigma, DMAIC, and other process-improvement tools and principles to day-to-day problem solving and continuous improvement.
• Help develop and release new products and processes using customer or internal specifications.
• Participate in process and equipment validations (IQ/OQ/PQ/MVP/TMV) and associated risk-management activities (PFMEA/Risk Assessment).
• Use process-improvement techniques to solve technical problems and recommend scale-appropriate equipment and processes.
• Help prepare engineering reports and communicate results to the technical team.
• Create process documentation and conduct training where applicable, including manufacturing-process, equipment-setup, and preventive-maintenance training.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level