Design Assurance Engineer
Are you an experienced Design Assurance Engineer with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Design Assurance Engineer to work at their company in Maple Grove, MN.
Position Summary : The Design Assurance Engineer is a quality engineer who directly supports medical device product development from concept through commercialization.
The employee will work with a high-performance cross-functional team to ensure safety, quality, and compliance throughout new product development.
This position will focus on establishing robust risk management, test method development, and design verification planning / testing through the new product development process.
This person will be working with a Design Assurance team of 8-9 people, including the manager, on a very highly new product development.
Primary Responsibilities / Accountabilities :
- Actively promote and participate in a cross-functional teamwork environment.
- Develop an understanding of Design Controls, Risk Management, and Usability for Medical Devices.
- Provide quality and compliance input to project teams for project decisions and deliverables (i.e., Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, Process Validation, and Labeling).
- Applies technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Successfully complete engineering work in one or more of the following : test method validation, risk management, bench and verification testing.
- Support development and coordinate the execution of Design Validation and Verification activities.
- Applying sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Support the verification, validation, and usability testing to meet or exceed internal and external requirements
- Perform regulatory standard assessments and support regulatory submissions to notified bodies.
- Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
Qualifications :
- Bachelor’s degree in mechanical, electrical, or biomedical engineering, or equivalent. FIRM.
- 1+ years of experience
Preferred :
- Focus on detailed work with an emphasis on accuracy and completeness
- Excellent organizational and planning skills; drives for results
- Strong communication (oral and written) and presentation skills
- Medical Device Experience
- Ability to collaborate on a cross-functional team
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