Sr. Design Assurance Engineer Direct Hire
Fridley, MN
Currently looking for a skilled individual to fill a Direct Hire Sr. Design Assurance Engineer position with a company in Fridley, MN.
Interested candidates should have a Bachelors Degree in an Engineering discipline, and 8+ years of experience creating and ensuring on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables.
Summary :
Directly supports medical device product development from concept through commercialization working with cross-functional development teams to establish and maintain the design control deliverables, risk management activities, and DHF compliance to ensure delivery of the highest quality product to the customer.
Sr. Design Assurance Engineer Job Description :
- Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects and leading on-time completion of protocols, reports and assigned project deliverables
- Accountable for Design Verification and Validation planning and / or, including active cross-functional root-cause analysis investigation & resolution activities
- Lead Risk Management activities from product Concept through Commercialization
- Support design test and inspection method development, and lead method validation activities
- Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
- Support and ensure internal & external audit responses and on-time product re-certifications
- Support and ensure the establishment of objective, measurable, discrete, and verifiable customer, and product requirements
- Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
- Provide support for biocompatibility and sterilization qualifications
- Develop and lead other team members and provide work direction as required
- May have 2-3 technicians assigned for inspection, testing and project support
- Performs other functions as required
Sr. Design Assurance Engineer Job Requirements :
- BS Industrial Engineering, Engineering or Business Degree
- 8-15 years of medical device experience in Quality Operations, or equivalent experience
- 1-3 years of supervisory experience preferred
- FDA regulations, ISO 13485, ISO 14971
- Statistical and data analysis
- Supervisory, Solid Management and Strong Leadership experience
- Prolonged periods sitting at a desk and working on a computer
- Must be able to lift 25 pounds at times
- Must have manual dexterity
- Must have excellent hand-eye coordination
- Must wear a gown, gloves, and ear protection if applicable
The starting salary for the Sr. Design Assurance Engineer position is $100K-$135K annually.
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