Design Assurance Engineer

Stark Pharma Solutions Inc; Waverly (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Design Controls

Risk Management

Cross-functional collaboration

Independent worker

Medical device experience

Job description

Job Summary

Client seeks an experienced Design Assurance Engineer to support design control and risk management activities within a cardiovascular medical device environment. The role will focus heavily on remediating existing quality documentation while also supporting ongoing product development and lifecycle activities.

Duration: 12 months

Location: Weaver Lakes, MN

Responsibilities

• Review and remediate design control and risk management documentation
• Support design inputs/outputs, design verification, and design validation activities
• Lead Test Method Validation (TMV) efforts and support test method development
• Lead and update FMEAs, hazard analyses, and other risk management documentation
• Ensure compliance with ISO 13485, ISO 14971, FDA requirements, and internal quality procedures
• Support remediation as well as PDP/NPD activities
• Participate in design reviews and other Design Assurance activities
• Potentially own or support CAPAs and NCRs
• Work autonomously while partnering cross-functionally with Engineering, Quality, Manufacturing, and Regulatory teams

Required

• 5+ years of Medical Device Design Quality / Design Assurance experience
• Strong Design Controls and Risk Management experience
• Design control and/or risk management remediation experience
• ISO 13485 and ISO 14971 experience
• Test Method Validation and test method development experience
• FMEA experience
• PDP/NPD experience
• Ability to work independently in a highly cross-functional environment
• Experience with products such as snares, clips, stents, or similar devices preferred

Desired

• Experience with Nitinol
• Experience with Cardiovascular products