Design Assurance Engineer
- Maple Grove, Minnesota
- Pharma & Biotech, Medical Devices, Engineering, Engineering & Validation, Quality Assurance (QA), Quality Assurance (QA), Test and Verification , Risk
Are you looking for an opportunity to do meaningful work that changes lives? Become a part of a team that is trusted partners of medical clinicians and the patients they serve. Offer practical solutions that build, nurture, and strengthen the vital parts at the heart of healthcare. We strive to improve the health and quality of people's lives. I am currently looking for a Design Assurance Engineer in our Maple Grove location.
In this role, as a Design Assurance Engineer you will fulfil design assurance on New Product development (conception to launch) and sustaining projects. You will lead planning and execution of Design Controls, Risk Management, Test Method Development and Validation, Design Verification/Validation for new and existing products.
Responsibilities are as follows:
- Design package up to contemporary standards
- Don't want to change the design - how would you define the design so it's clear and better control on how to make it
- Make sure it's defined well enough so that they can support it
- Meet contemporary standards
- Test Methods were never validated
- Redefinition of design inputs
- Clearly linking design outputs to design inputs
- Participate and lead New Product Development Phase Reviews and Design Reviews.
- Partner with R&D to determine and define design inputs, design outputs, and design input/output relationships.
- Create and support the development and validation of new test methods.
- Determine and document risks associated with the product (Hazard Analysis, DFMEA, PFMEA, UFMEA).
- Develop the strategy and manage the execution of design verification and validation.
- Generate test protocols, manage test execution, investigate test issues, analyze data, and create reports for design verification and validation testing.
- Develop, execute, and manage First Article inspections.
- Provide direction to design assurance engineering technicians supporting assigned projects.
- Support improvement of Design Assurance specific quality system deliverables and processes to increase effectivity and efficiency.
- Support regulatory approvals and responses to regulatory questions.
- Support Sustaining Engineering for design and process changes to commercialized product.
- Support the transfer of new product development projects from development to production.
- Support internal and external audits.
- Ability to work independently and with general direction.
- Ability to define, organize, and manage individual and team based tasks.
- Provide direction to extended team members.
- Effective verbal and written communication.
- Proficient in technical report writing and review.
- Interpersonal skills; working in a team and as an individual contributor.
- Structured and methodical problem-solving approach.
- Basic understanding of design controls, risk management, statistics, test method validation, and new product development processes.
- Basic understanding of industry regulations such as ISO13485 and FDA QSR's.
Sthree US is acting as an Employment Business in relation to this vacancy.