NPI Engineer II

Resonetics•Westborough, MA

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 successful market introduction and launch. Working with Product Development and Quality Engineering, the engineer implements new technologies and processes and transfers them to clinical, pilot-line, and commercial production while meeting goals for safety, quality, delivery, cost, and productivity. The role develops, selects, and optimizes component and assembly manufacturing systems based on planned demand, location, and quality requirements. It also contributes to selecting, vetting, and coordinating external supply-chain partners. As programs move into commercial manufacturing, the NPI Engineer serves as a technical liaison and supports the transfer team, including training 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 and 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 software for tooling and fixture design.
Knowledge of GD&T and technical drawing generation.
Excellent writing skills, including the ability to write detailed reports, manufacturing procedures, and validation reports or protocols.
Training or experience in formal problem-solving techniques, such as cause-and-effect analysis and 5 Whys.
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 and ensure processes and documentation comply with established policies, procedures, and Resonetics’ Quality Management System.
Use LEAN, Six Sigma, DMAIC, and other process-improvement tools and principles for 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).
Apply process-improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
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.
Support transfer to clinical, pilot-line, and commercial production, including facilitating training of production resources.