Senior Medical Device Design Assurance Engineer

Pharmavise Corporation; Maple Grove (MN); On-site; USD 110,000 - 140,000; Full time

Job summary

Pharmavise Corporation is seeking a Senior Design Assurance Engineer for an onsite role in Arbor Lakes, MN. The position focuses on leading design assurance activities, driving ISO 14971 risk management, and overseeing V&V efforts for medical devices in a contract engagement.

Responsibilities include creating quality plans and risk management workflows, supporting post-market activities, and ensuring compliance with QSR and ISO standards, with an emphasis on reliability and electrical safety.

Qualifications

• Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline.
• 5+ years of related experience in design assurance, new product development, or regulated industry experience.
• Understanding of electrical safety standards IEC 60601.
• Experience with reliability testing.
• Demonstrated use of quality tools/methodologies.

Responsibilities

• Lead design assurance activities and drive ISO 14971 risk management processes.
• Support V&V, verification protocols, tests and reports for quality and compliance.
• Assist in risk documentation and post-market record review during remediation activities.

Skills

Quality tools/methodologies

Electrical safety knowledge

Reliability testing

Education

Bachelors in Mechanical/Electrical/Biomedical Engineering

Job description

Pharmavise Corporation is seeking a Senior Design Assurance Engineer for an onsite role in Arbor Lakes, MN. The position focuses on leading design assurance activities, driving ISO 14971 risk management, and overseeing V&V efforts for medical devices in a contract engagement.

Responsibilities include creating quality plans and risk management workflows, supporting post-market activities, and ensuring compliance with QSR and ISO standards, with an emphasis on reliability and electrical safety.