Design Assurance Engineer
4 days ago
Title: Design Assurance Engineer
Location: St. Paul, MN - 55117
Duration: 2 + Months
Description:
Position Summary:
- A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the companys products conform to quality standards.
- You will partner with research/development and manufacturing engineering during new product start-ups and establishes checkpoints for testing new products and processes. The design assurance engineer is responsible for following established GMP/ISO compliant quality system practices.
Essential Functions:
1. Ensure companys adherence to the established Quality System and GMP/ISO standards, including ongoing establishment and improvement to the quality system procedures.
2. Lead design assurance activities in support of development for electromechanical systems that utilize microcontroller technology, customized/off the shelf PCBs and software applications.
3. Manage new product Design History Files.
4. Work with Engineering, Marketing, Manufacturing and Regulatory to establish measurable, valid product requirements.
5. Aide in definition of test equipment as required to accomplish quality responsibilities.
6. Develops and documents test plan protocols, test procedures, and test reports.
7. Perform tests according to various protocol requirements.
8. Lead completion of risk management and risk analysis including FMEA.
9. Devise design verification and design validation plans for products based on performance specifications and risk analysis
10. Analyze and communicate conformance to specifications and standards.
11. Conducts technical and statistical investigations concerning compliance to specification and optimization of design relevant to specification.
12. Support completion of in vitro testing including applicable animal studies.
13. Aide in definition of supplier quality specifications, sampling plans, and vendor qualification.
14. Assist in specifications and testing of sterilization methods.
15. Lead system and product continuous improvement teams.
16. Reviews Engineering Change Orders, as required.
17. Perform other duties and responsibilities as assigned by senior management.
-
Design Assurance Engineer
6 days ago
St Paul, United States ICONMA Full timeDesign Assurance Engineer Location: St. Paul, MN Position Summary: A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance...
-
Design Assurance Engineer
5 days ago
St Paul, United States SPECTRAFORCE Full timeJob Title: Engineer, Design Assurance Duration: 4+ Months Location: St. Paul, MN (55117) Shift: 8 am - 5 pm Min pay rate starts from: $60/hr on W2 Job Description: A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel...
-
Design Assurance Engineer
7 days ago
St Paul, United States SPECTRAFORCE Full timeJob Title: Engineer, Design AssuranceDuration: 4+ MonthsLocation: St. Paul, MN (55117)Shift: 8 am - 5 pmMin pay rate starts from: $60/hr on W2 Job Description:A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel...
-
Design Assurance Engineer
2 days ago
St Paul, United States ICONMA Full timeA Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the companys products conform to quality...
-
Design Assurance Engineer
7 days ago
St Paul, United States Intellectt Inc Full timeJob Duties: A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the companys products conform to...
-
Design Assurance Engineer
5 days ago
St Paul, United States ICONMA Full timeA Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality...
-
Design Assurance Engineer
6 days ago
St Paul, United States Intellectt Inc Full timeRole: Design Assurance EngineerLocation: St. Paul, MN - 55117Duration: 6 Months on W2Skills Looking For:- Design Assurance Engineer position.- Domain: Design and development- medical electrical equipment.- Computer science background, med device software development background (not writing code, heavily involved in verification and validation of medical...
-
Design Assurance Engineer
7 days ago
Saint Paul, United States SPECTRAFORCE Full timeJob Title: Engineer, Design AssuranceDuration: 4+ MonthsLocation: St. Paul, MN (55117)Shift: 8 am - 5 pmMin pay rate starts from: $60/hr on W2 Job Description:A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel...
-
Design Assurance Engineer
7 days ago
Saint Paul, United States Intellectt Inc Full timeJob Duties: A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality system. You will work closely with Regulatory Affairs personnel (internal or external) to monitor regulatory compliance. You will monitor quality assurance efforts to ensure that the companys products conform to...
-
Design Assurance Engineer
1 week ago
Saint Paul, United States Select Source International Full timeJob DescriptionJob DescriptionJob Title: Design Assurance EngineerLocation: One St Jude Medical Drive St. Paul, MN 55117Duration: 05 Months Contract with possible extensionPay Rate/Range: $70/hr on w2 w/o benefits.Job Description:A Design Assurance Engineer works closely with development/manufacturing/quality engineering to ensure compliance with the quality...
-
Senior Design Quality Assurance Engineer
1 week ago
St Paul, United States Boston Scientific Full timeAdditional Location(s): N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
-
Senior Design Quality Assurance Engineer
7 days ago
St Paul, United States Boston Scientific Full timeAdditional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest...
-
Design Assurance Engineer
2 months ago
Saint Paul, United States Ativa Medical Corporation Full timeJob DescriptionJob DescriptionDesign Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.Essential Job Duties...
-
Design Assurance Engineer
4 weeks ago
Saint Paul, United States Ativa Medical Corporation Full timeJob DescriptionJob DescriptionDesign Assurance engineer to represent the Quality function on a product development team. This engineer would be a key contributor to risk management and design verification planning and execution. Secondarily, this position would also provide support for supplier management and material quality activities.Essential Job Duties...
-
Design Assurance Engineer
2 days ago
Saint Paul, United States Intellectt Inc Full timeRole: Design Assurance EngineerLocation: St. Paul, MN - 55117Duration: 6 Months on W2Skills Looking For:- Design Assurance Engineer position.- Domain: Design and development- medical electrical equipment.- Computer science background, med device software development background (not writing code, heavily involved in verification and validation of medical...
-
Senior Design Assurance Engineer
1 month ago
Saint Paul, United States Cypress HCM Full timeJob DescriptionJob Description Senior Design Assurance Engineer Responsibilities:• Core Team member of medical device development project teams to ensure compliance to Design Controls requirements.• Responsible for quality activities and deliverables on the cross-functional development team.• Responsible for strategic quality planning activities on the...
-
Senior Design Assurance Engineer
4 weeks ago
Saint Paul, United States Cypress HCM Full timeJob DescriptionJob Description Senior Design Assurance Engineer Responsibilities:• Core Team member of medical device development project teams to ensure compliance to Design Controls requirements.• Responsible for quality activities and deliverables on the cross-functional development team.• Responsible for strategic quality planning activities on the...
-
Structural Engineer
1 day ago
St Paul, United States The Haskell Company Full timeStructural Engineer - Industrial Design Job Locations US-MN-St Paul | US-MO-St. Louis Requisition ID 1445 Category Engineering Overview Are you ready to move your career forward, and start the BEST job of your life? Haskell is committed to providing you with the resources to help you grow and discover your potential. We promote an environment that encourages...
-
Senior Structural Engineer
2 days ago
St Paul, United States The Haskell Company Full timeSenior Structural Engineer - Industrial Design Job Locations US-MO-St. Louis | US-MN-St Paul Requisition ID 1470 Category Engineering Overview Are you ready to move your career forward, and start the BEST job of your life? Haskell is committed to providing you with the resources to help you grow and discover your potential. We promote an environment that...
-
Structural Engineer
4 weeks ago
St. Paul, United States The Haskell Company Full timeStructural Engineer - Industrial Design Job Locations US-MN-St Paul | US-MO-St. Louis Requisition ID 1445 Category Engineering Overview Are you ready to move your career forward, and start the BEST job of your life? Haskell is committed to providing you with the resources to help you grow and discover your potential. We promote an...