- Support and execute product development deliverables.
- Develop and maintain Design History File (DHF) documentation that is complete, accurate, and compliant.
- Help define and maintain customer requirements, product requirements, and specifications.
- Lead and support product risk management activities.
- Write design verification and validation plans and reports.
- Support sampling inspection plans and qualification of purchased components.
- Contribute to test method development and lead method validation.
- Use statistical tools to support characterization, verification, validation, and root cause analysis.
- Support quality system activities, including non-conformances and CAPAs.
- Perform other related duties as needed.
- 5+ years of engineering or quality experience in the medical device industry.
- Ability to work independently with limited supervision.
- Strong understanding of Quality Systems and documentation practices.
- Experience with CAPA investigations and implementation.
- Experience with design controls and test method validation.
- Familiarity with EU MDR, FDA 21 CFR, TGA regulations, ISO 14971, and ISO 13485.
- Strong written and verbal communication skills.
- Comfortable collaborating with multidisciplinary engineering teams.
-
Quality Assurance Engineer
6 days ago
Only for registered members MinneapolisSeeking a Quality Assurance professional to support quality systems and compliance activities in a regulated medical device environment. · Support QMS activities in compliance with FDA 21 CFR 820 and ISO 13485. · ...
-
Design Assurance Engineer
3 weeks ago
Only for registered members MinneapolisAn established Medical Device company is seeking an experienced Design Quality Engineer. · ...
-
Quality Assurance Engineer
1 month ago
Only for registered members MinneapolisWe are looking for an experienced QA Engineer with strong expertise in C#, Selenium automation, and deep exposure to healthcare standards and imaging systems.The ideal candidate will have hands-on experience in Medicare/Medicaid (Medicate) domain, along with solid knowledge of HL ...
-
Quality Assurance Engineer
2 weeks ago
Only for registered members MinneapolisThe Quality Assurance Engineer assists efforts associated with ensuring products released to customers error-free and with expected or better performance. This includes providing input on the design, and direct engagement in the development and implementation of an automated test ...
-
Quality Assurance Engineer
6 days ago
Only for registered members Minneapolis, MNWe are seeking a Quality Assurance professional to support quality systems and compliance activities in a regulated medical device environment. · Support QMS activities in compliance with FDA 21 CFR 820 and ISO 13485. · Review and approve quality documents (SOPs, CAPA, deviations ...
-
Design Assurance Engineer
1 month ago
Only for registered members Minneapolis+Job summary · As a Design Assurance Engineer, you will play a pivotal role in supporting the development and assurance of new products. · You will engage in phase reviews and design reviews, collaborating closely with R&D to manage design inputs and outputs, ensuring adherence t ...
-
Design Assurance Engineer
1 month ago
Only for registered members MinneapolisAs a Design Assurance Engineer, you will play a pivotal role in supporting the development and assurance of new products. · ...
-
Design Assurance Engineer
2 weeks ago
Only for registered members MinneapolisAs a Design Assurance Engineer at Actalent you will play a pivotal role in supporting the development and assurance of new products. You will engage in phase reviews and design reviews collaborating closely with R&D to manage design inputs and outputs ensuring adherence to design ...
-
Quality Assurance Engineer
1 month ago
Only for registered members Minneapolis, MNThe Quality Engineer at Interrad Medical fulfills a multi-functional role providing Quality Assurance support to Manufacturing Operations and Engineering This job is full-time on-site in Plymouth MN The Quality Engineer reports to the Quality Assurance ManagerIdentify opportuniti ...
-
Design Assurance Engineer
2 days ago
Only for registered members MinneapolisSupport the development and assurance of new products. · Participate in New Product Development Phase Reviews. · Collaborate with R&D to define and manage design inputs and outputs. · ...
-
Quality Assurance Engineer
1 month ago
Only for registered members Minneapolis $60,000 - $90,000 (USD)The Quality Engineer at Interrad Medical fulfills a multi-functional role. The job is full-time and on-site in Plymouth MN. · Identify opportunities and coordinate company-wide efforts to maintain and continuously improve the Quality Management System for Interrad Medical. · Ensu ...
-
Design Assurance Engineer
3 days ago
Only for registered members MinneapolisAs a Design Assurance Engineer you will play a pivotal role in supporting the development and assurance of new products. · ...
-
Design Assurance Engineer
1 month ago
Only for registered members MinneapolisThis Senior Design Quality Engineer will lead design control deliverables and ensure on-time design verification. · ...
-
Design Assurance Engineer
1 day ago
Only for registered members Minneapolis, MN+ Participate in New Product Development Phase Reviews and lead or participate in Design Reviews. · + Collaborate with R&D to define and manage design inputs and outputs.Essential Skills · Degree in Engineering, preferably Electrical or Software Engineering. · Minimum of 2 years ...
-
Design Assurance Engineer
1 month ago
Only for registered members MinneapolisThe Interventional Urology Design Assurance Engineer is responsible for supporting new product development and commercialized products. · The role involves participating in New Product Development Phase Reviews, leading/participating in Design Reviews, · partnering with R&D to de ...
-
Design Assurance Engineer
1 month ago
Only for registered members Minneapolis, MNAs a Senior Design Quality Engineer you will be responsible for leading the creation and implementation of all design control deliverables. · Lead the creation and implementation of design control deliverables. · Plan and execute design verification and validation activities incl ...
-
Quality Assurance Engineer
1 month ago
Only for registered members MinneapolisWe are looking for strong QA Engineers who ensures the quality, reliability, and usability of software and hardware products. · ...
-
Quality Assurance Engineer
3 weeks ago
Only for registered members Minneapolis+Job summary · QA engineer role with 19 positions available in Minneapolis, MN. · +Medicaid · Snap · Tanf+ Strong knowledge of child support application testing. Participate as needed in specific testing activities (reviews, walk-thru's etc) Create test scenarios, test cases (det ...
-
Quality Assurance Engineer
3 weeks ago
Only for registered members Minneapolis, MNA QA Engineer with strong knowledge of child support application testing will participate in specific testing activities, create test scenarios and cases, and ensure correct traceability. · ...
-
Senior Design Assurance Engineer
1 month ago
Only for registered members Minneapolis, MNWe're looking for a Senior Design Assurance Engineer in Maple Grove to support innovative medical device development. · You'll lead design assurance activities and collaborate with cross-functional teams. · ...
-
Senior Design Assurance Engineer
1 month ago
Only for registered members MinneapolisWe are looking for a Senior Design Assurance Engineer in Maple Grove MN to support innovative medical device development. · You ll lead design assurance activities ensure compliance with regulatory standards and collaborate with cross functional teams to bring safe high quality p ...
Senior Design Assurance Engineer - Minneapolis - Brio Group
Description
The Senior Design Assurance Engineer supports product development to ensure smooth production launch and high-quality product delivery. The role also assists with design changes and broader quality initiatives. It works closely with Engineering, Operations, Quality, Marketing, and Regulatory teams and is responsible for following all Quality Management System and safety requirements.
Responsibilities
Qualifications
-
Quality Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis, MN
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis, MN
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis, MN
-
Design Assurance Engineer
Only for registered members Minneapolis
-
Design Assurance Engineer
Only for registered members Minneapolis, MN
-
Quality Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis
-
Quality Assurance Engineer
Only for registered members Minneapolis, MN
-
Senior Design Assurance Engineer
Only for registered members Minneapolis, MN
-
Senior Design Assurance Engineer
Only for registered members Minneapolis