Compliance Engineer IV

4 days ago


Charlton, Massachusetts, United States KARL STORZ Endoscopy - America Full time

About Us:

KARL STORZ Endoscopy - America is a globally independent, family-operated MedTech company that prioritizes long-term thinking and innovation. Our 9,000+ global associates are dedicated to harnessing leading technologies, precise workmanship, and customer-centric support to drive the future of medical technology.

Job Summary:

We are seeking a detail-oriented Compliance Engineer IV to oversee component planning with Electronics Engineers globally and play a crucial role in establishing global standards. As a key technical interface between suppliers and development engineers, you will drive improvements in quality, reliability, and cost-effectiveness.

Key Responsibilities:

  • Lead global initiatives in component selection, research, and documentation to meet quality, manufacturability, and regulatory requirements.
  • Develop and maintain global guidelines, including preferred parts, derating, and tolerance analysis.
  • Collaborate with Electronics Engineers on component analysis, cost reduction strategies, and specifications.
  • Manage component compliance in line with regulations like China RoHS and REACH, coordinating with QA and Material Compliance teams.
  • Facilitate end-of-life (EOL) projections and manage EOL replacement efforts with cross-functional teams.
  • Evaluate supplier change notifications, qualify changes, and provide expert support in design reviews.
  • Act as the Altium schematic and PWB design tool librarian, maintaining the global parts library.
  • Ensure compliance with global regulatory standards and provide training on component selection and characteristics.
  • Participate in product development teams to create, manage, and audit design history files and technical documentation through the design control process.
  • Ensure compliance with FDA/QSR and ISO design control regulations.
  • Develop standards of best practice to be applied to Flexible Endoscope Development projects and, as applicable, the global Product Development group.
  • Participate in and lead (as required) global project teams working to ensure continued compliance with national and international standards.
  • Responsible for participating in the Design Controls portion of all regulatory agency audits which involve Flexible Endoscope Development.
  • Perform internal audits of Design History Files, technical documentation, and FED procedures and documentation to ensure compliance.
  • Investigate and respond to corrective actions in a timely manner.
  • Serve as a point of contact for KARL STORZ Regulatory Departments.
  • Responsible for understanding the application of relevant standards to the activities of Flexible Endoscope Development, to stay current on new revisions, and to ensure compliance.
  • Performance of gap analysis for revised applicable standards.
  • Identify and review new standards to determine applicability to Flexible Endoscope Development instruments.

Requirements:

  • Bachelor's degree required - Mechanical, Electrical or Software Engineering preferred and a minimum of 10 years in component engineering.
  • 8 or more years of experience in a Medical Device design / manufacturing environment working under FDA and/or ISO regulations.
  • Experience in new product development of reusable medical devices required.
  • Familiarity with U.S. FDA Quality System Regulation (21 CFR Part 820) and international quality standards (ISO 13485, ISO).
  • Ability to evaluate electronic component data sheets and their application in specific circuit designs preferred.

About You:

We are looking for a highly skilled and experienced Compliance Engineer IV to join our team. If you have a passion for compliance and engineering, and a strong background in component engineering, we encourage you to apply.



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