Sr. Development Quality Engineer
5050 Nathan Lane North Plymouth, MN 55442 US
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.
RESPONSIBILITIES
- 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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