Design Assurance Engineer - Medical Devices Quality Leader

Medical Engineering Consultants (MEC); Maple Grove (MN); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

AAP/EEO DFWP

Job summary

Medical Engineering Consultants (MEC) is hiring a Contract Design Assurance Engineer in Minnesota to lead design quality, DHF, risk management and post-market processes within a large medical device setting. The role emphasizes collaboration across engineering, QA and manufacturing to ensure robust compliance and continuous improvement.

Ideal candidates have extensive QA leadership experience with interventional cardiology exposure, a strong quality system background, and hands-on DHF

Qualifications

• 9–13 years of experience with BS
• 7–11 years with MS
• 4–8 years with PhD

Responsibilities

• Provides leadership role on championing departmental or cross-functional engineering initiatives.
• Provides project direction, coaching and mentoring for engineering and technical team personnel.
• Proactively investigates, identifies and implements best-in-class Quality Engineering practices.
• Mentor for technical guidance for identifying and resolving quality issues.
• Identifies and implements effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.
• Leads in the implementation of assurances, process controls and CAPA systems designed to meet or exceed internal and external requirements.
• Acts as an effective leader or team member in supporting quality disciplines, decisions and practices.
• Applies sound systematic problem-solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.

Skills

Design quality leadership

Interventional cardiology experience

Quality systems knowledge

Cross-functional mentoring

Problem solving

Education

BS

MS

PhD

Job description

Medical Engineering Consultants (MEC) is hiring a Contract Design Assurance Engineer in Minnesota to lead design quality, DHF, risk management and post-market processes within a large medical device setting. The role emphasizes collaboration across engineering, QA and manufacturing to ensure robust compliance and continuous improvement.

Ideal candidates have extensive QA leadership experience with interventional cardiology exposure, a strong quality system background, and hands-on DHF