Advanced Product Introduction Engineer

1 week ago


Westborough, Massachusetts, United States Resonetics Full time

Overview

The NPI (New Product Introduction) Engineer at Resonetics plays a crucial role in ensuring the documentation of innovative medical device manufacturing processes for seamless transition from development to large-scale production. Collaborating closely with Product Development and Quality Engineering teams, this position is vital for achieving a successful and timely shift from development to commercial manufacturing while adhering to key objectives such as safety, quality, delivery, cost, and productivity.

Key Responsibilities

  • Launch new products and processes based on customer or internal specifications.
  • Document manufacturing protocols, tools, and fixtures to ensure adequate capacity for customer demand while enhancing product quality, process efficiency, and operator safety.
  • Create and update manufacturing process documentation, ensuring compliance with Resonetics' established Quality Management System.
  • Employ LEAN, Six Sigma, DMAIC, and other process enhancement methodologies for ongoing improvement.
  • Conduct risk management activities, including PFMEA and Risk Assessments.
  • Promote the use of process improvement techniques to recommend suitable equipment and processes.
  • Develop process documentation and conduct training as necessary (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 abilities, comfortable leading and providing project updates to team members, customers, and leadership.
  • Proven work ethic and understanding of deadline management.
  • 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, capable of producing detailed reports, comprehensive manufacturing procedures, and validation reports/protocols.
  • Effective interpersonal skills, adept at engaging with diverse departments in a multicultural workforce.
  • Ability to clarify tasks in a dynamic environment with cross-functional stakeholders.

Compensation

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

Resonetics is dedicated to providing equal opportunity for all employees and applicants, without regard to race, color, religion, sex, sexual orientation, age, national origin, ancestry, disability, or veteran status. Hiring decisions are based on Resonetics' operational needs and applicant merit, including qualifications, experience, ability, availability, cooperation, and job performance.



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