Senior NPI Engineer

2 weeks ago


Westborough, Massachusetts, United States Resonetics Full time

Overview

The NPI (New Product Introduction) Engineer at Resonetics plays a vital role in documenting innovative medical device manufacturing processes, facilitating the transition from development to large-scale production. Collaborating closely with Product Development and Quality Engineering teams, the NPI Engineer ensures a smooth and timely shift to commercial manufacturing while adhering to established objectives such as safety, quality, delivery, cost, and productivity.

Key Responsibilities

  • Launch new products and processes based on customer or internal specifications.
  • Document manufacturing procedures, tools, and fixtures to ensure adequate capacity for customer demand while enhancing product quality, process efficiency, and operator safety.
  • Create and revise manufacturing process documentation, ensuring compliance with Resonetics' Quality Management System.
  • Employ LEAN, Six Sigma, DMAIC, and other process improvement methodologies for ongoing enhancements.
  • Conduct risk management activities, including PFMEA and Risk Assessments.
  • Promote the use of process improvement techniques to recommend appropriate equipment and processes for scaling.
  • Develop process documentation and conduct training as necessary (including Manufacturing Process, Equipment Setup, Preventive Maintenance, etc.) along with associated risk management activities.

Qualifications

  • Bachelor's degree or higher in a relevant Engineering discipline or equivalent experience.
  • A minimum of 4 years of experience in a manufacturing setting within an engineering capacity.
  • Strong communication skills, capable of leading and providing project updates to team members, customers, and leadership.
  • Demonstrated work ethic and proficiency in managing deadlines.
  • Proficient in SolidWorks (or equivalent) for tooling and fixture design, with knowledge of GD&T and technical drawing generation.
  • Familiarity with risk management processes (PFMEA/Risk Assessment).
  • Exceptional writing skills, able to produce detailed reports, comprehensive manufacturing procedures, and validation documents.
  • Strong interpersonal skills, with the ability to engage effectively with diverse departments.
  • Ability to provide clarity on tasks in a dynamic environment with cross-functional stakeholders.

Compensation

Pay Range: $80,000-$100,000

Resonetics is dedicated to ensuring equal opportunity for all employees and applicants, regardless of race, color, religion, sex, sexual orientation, age, national origin, ancestry, disability, or veteran status. Hiring decisions are based on operational needs and applicant merit, including qualifications, experience, availability, cooperation, and job performance.



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