Senior Design Assurance Engineer - Medical Devices (12-Month Contract)

Stark Pharma Solutions Inc; Waverly (MN); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Stark Pharma Solutions Inc in Minnesota is seeking an experienced Design Assurance Engineer to support design control and risk management in a cardiovascular medical device environment. The role focuses on remediating existing quality documentation while supporting ongoing product development and lifecycle activities.

This is a 12-month assignment located at Weaver Lakes, MN, requiring strong ISO 13485 and ISO 14971 experience, FMEA capabilities, and PDP/NPD familiarity, with the ability to work

Qualifications

• 5+ years of Medical Device Design QA/Design Assurance experience.
• Strong design controls and risk management experience.
• ISO 13485 and ISO 14971 experience.
• FMEA and risk documentation experience.
• PDP/NPD experience and CAPA/NCR familiarity.
• Ability to work independently in cross-functional environment.

Responsabilités

• Review and remediate design control and risk management documentation.
• Support design inputs/outputs, verification, and validation activities.
• Lead TMV efforts and support test method development.
• Lead/update FMEAs, hazard analyses, and risk management docs.
• Ensure ISO/FDA compliance and internal quality procedures.
• Support remediation as well as PDP/NPD activities.
• Participate in design reviews and Design Assurance activities.
• Potentially own or support CAPAs and NCRs.
• Collaborate cross-functionally with Engineering, Quality, Manufacturing, and Regulatory.

Connaissances

Design Controls

Risk Management

Cross-functional collaboration

Independent worker

Medical device experience

Description du poste

Stark Pharma Solutions Inc in Minnesota is seeking an experienced Design Assurance Engineer to support design control and risk management in a cardiovascular medical device environment. The role focuses on remediating existing quality documentation while supporting ongoing product development and lifecycle activities.

This is a 12-month assignment located at Weaver Lakes, MN, requiring strong ISO 13485 and ISO 14971 experience, FMEA capabilities, and PDP/NPD familiarity, with the ability to work