NPI Engineer II

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

Overview

Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.

The NPI Engineer is a key member of the team ensuring Resonetics’ ability to develop cutting edge medical device products and manufacturing capabilities from early stage design through successful market introduction and launch. They work in unison as a core team member with the Product Development and Quality Engineering functions to implement new technologies and processes, and ensure successful and timely transfer to clinical, pilot-line, and commercial production while meeting established goals (i.e., safety, quality, delivery, cost, and productivity). The NPI Engineer develops, selects, and optimizes systems for component and assembly manufacturing based on planned demand, location, and quality requirements. In addition, the NPI Engineer plays a key role in selection, vetting, and coordination of external supply chain. As programs progress into commercial manufacturing, the NPI Engineer acts as a technical liaison and key member of the transfer team to facilitate efficient training of production resources.

Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you.

Responsibilities

• Design and develop manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
• Provide production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
• Generate and modify manufacturing process documentation and assure that manufacturing processes and related documentation follow established policies and procedures per Resonetics’ established Quality Management System.
• Utilize LEAN, Six Sigma, DMAIC and other process improvement tools and principles as appropriate 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), as well as associated risk management activities (PFMEA/Risk Assessment).
• Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
• Help prepare engineering reports, communicate results to technical team.
• Create process documentation and execute training where applicable (Manufacturing Process, Equipment Setup, Preventive Maintenance etc.).

Required Qualifications

• (BS or MS) in relevant Engineering discipline or equivalent experience.
• Minimum of 1 year experience in a manufacturing environment working in an engineering role.
• Strong communication skills, comfortable with providing project status updates at the team level.
• Demonstrated work ethic and understanding of deadline management.
• Strong analytical skills with the ability to process operational or technical data.
• Familiarity with conventional statistical analyses (process capability, equivalence studies, regression, ANOVA, DOE).
• Proficient in SolidWorks (or equivalent) for tooling/fixture design. Well versed in GD&T and generation of technical drawings.
• Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols.
• Training and/or experience in formal problem-solving techniques (Cause & effect analysis, 5 Why’s, etc.)
• Effective interpersonal skills and adeptness in working with culturally diverse employee population.
• Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.

Preferred Qualifications

• Experience in 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.

Physical Demands

• Standing and walking for short periods of time
• Ability to use a microscope, including manipulating small objects under a microscope

Compensation

The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $65,000-94,000

Our company policy is that we are unable to provide visa sponsorship. Candidates must already be legally authorized to work in the United States without the need for sponsorship now or in the future.