Sr. / Principal Design Assurance Engineer - Medical Device

ZipRecruiter; Minneapolis (MN); On-site; USD 115,000 - 150,000; Full time

Job summary

A leading company in the medical device industry is seeking a Senior/Principal Design Assurance Engineer in Minneapolis. This role involves leading design assurance activities, ensuring compliance with FDA and ISO standards, and collaborating with cross-functional teams. The ideal candidate will have extensive experience in medical device design assurance and a strong understanding of regulatory requirements.

Qualifications

• 5+ years of experience in medical device design assurance.
• Strong understanding of FDA and ISO 13485 regulatory requirements.

Responsibilities

• Lead design assurance activities ensuring compliance with regulatory standards.
• Conduct risk management assessments and collaborate with product development teams.

Skills

Communication

Problem Solving

Education

Bachelor’s degree in Biomedical Engineering

Bachelor’s degree in Mechanical Engineering

Job description

Job Title:

Senior / Principal Design Assurance Engineer

Location:

Minneapolis, MN

Job Type:

Direct Hire

Position Overview:

We are seeking an experienced Senior Design Assurance Engineer in the Minneapolis area. This role offers an exciting opportunity to contribute to the development and validation of innovative medical devices in a collaborative, fast-paced environment. As a key member of the design assurance team, you will play a critical role in ensuring the safety, effectiveness, and regulatory compliance of medical device products.

Key Responsibilities:

1. Lead and support design assurance activities throughout the product development lifecycle, ensuring compliance with regulatory standards (FDA, ISO, etc.).
2. Review and approve design documentation, including design control deliverables (Design Inputs, Design Outputs, Design Verification/Validation).
3. Provide guidance and support to cross-functional teams in the implementation of risk management processes (FMEA, Hazard Analysis, Risk Assessment).
4. Conduct and document risk management assessments and collaborate with product development teams to mitigate identified risks.
5. Support the creation and execution of design validation and verification protocols, ensuring adherence to quality and regulatory standards.
6. Participate in design reviews and provide expert feedback on product designs, including design transfer activities and design history file maintenance.
7. Work closely with quality assurance, regulatory, and manufacturing teams to ensure seamless transitions between design and production stages.
8. Contribute to the preparation for regulatory inspections, audits, and external assessments.
9. Ensure that design control documentation, test protocols, and reports meet FDA and ISO 13485 guidelines.

Qualifications:

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or related field (or equivalent experience).
• 5+ years of experience in medical device design assurance, with a deep understanding of FDA and ISO 13485 regulatory requirements.
• Proven experience working with design control processes, including design verification/validation, risk management, and design documentation.
• Experience with regulatory submissions, audits, and inspections.
• Strong understanding of risk management techniques (e.g., FMEA, Fault Tree Analysis).
• Excellent communication and interpersonal skills, with the ability to work cross-functionally with diverse teams.
• Ability to manage multiple projects in a fast-paced, dynamic environment.
• Experience with quality management systems (QMS) and maintaining a design history file (DHF) is highly desirable.
• Strong problem-solving skills, attention to detail, and the ability to anticipate and mitigate potential risks in the development process.

Additional Qualifications:

• Experience with medical device combination products or active implantable devices.
• Six Sigma or other process improvement certifications are a plus.

Compensation:

• $115k-$150k

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