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Sr. Development Quality Engineer

Plymouth, MN 55442

Posted: 09/22/2023 Employment Type: Contract Job Category: Engineering Job Number: 585994 Is job remote?: No Country: United States

Job Description

The Sr. Development Quality Engineer will serve as a technical representative providing design quality expertise to a product development team. Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

  • Lead and/or support on-time completion of Design Control deliverables
  • Support the establishment of objective, measurable, and verifiable product requirements
  • Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
  • Lead Risk Management activities from product concept through commercialization
  • Support test method development and lead test method validation activities
  • Support manufacturing process development & qualification for new product and design changes
  • Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
  • Support biocompatibility and sterilization qualifications
  • Support audits and quality system improvement activities
  • Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
  • Comply with U.S. FDA, EUMDR and other requirements, as applicable.
  • Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.

Basic Qualifications:
  • Bachelors degree in Engineering or Technical Field.
  • Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
  • Experience in medical devices and associated regulations/standards.
  • Experience in test method development and validation
  • Experience in preparing risk assessments, FMEA and other risk documents.

Preferred Qualifications:
  • Advanced Degree in Engineering/Technical Field
  • Experience in active implantable medical devices.
  • Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
  • Working knowledge of statistics and its application to verification and validation
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