Design Assurance Engineer II

Minnetonka, MN / Hybrid

Schedule: Standard Office Hours

Duration: 3-Month Contract

Pay Range: $43-48/ph

Position Summary

In this role, you will lead quality engineering activities for development projects, including risk management file creation, design verification/validation, and development of Design History File (DHF) deliverables. This position also involves supporting design changes for commercial products to ensure product quality, reliability, and compliance.

Key Responsibilities

• Drive quality, reliability, and regulatory compliance for mechanical product designs.
• Lead design control deliverables and ensure timely completion.
• Critically evaluate product designs, identify quality issues, and drive resolution.
• Develop risk management files and reports for product releases, maintaining accountability from conception to commercialization.
• Plan and oversee release testing for new products.
• Ensure DHF and Device Master Record (DMR) completion, regulatory compliance, and gap resolution.
• Support quality system development and continuous improvement.
• Define, validate, and update print specifications and inspection methods.
• Conduct design verification/validation and reliability studies.
• Execute Quality Plans for OEM manufacturing projects and design changes.
• Contribute to manufacturing process qualification for product commercialization.
• Assist with internal and external audits, complaint investigations, and product quality investigations.
• Collaborate cross-functionally to protect patient/user safety and achieve business objectives.

Qualifications

• Education: Bachelor's degree in Engineering (Mechanical, Material Science, Biomedical, or related field).
• Experience: 3+ years in the medical device industry or related fields (or an equivalent combination of education and experience).

Preferred Skills and Competencies:

• Knowledge of GMP, ISO, QSR, and other regulatory standards.
• Strong statistical data analysis skills.
• Proven ability to manage multiple projects.
• Excellent written and verbal communication skills.
• Ability to work independently and collaboratively within cross-functional teams.
• Customer-focused and service-oriented mindset.
• Background in Six Sigma or Critical to Quality methodologies is a plus.
• Familiarity with drug-device combination products and sterile pharmaceutical environments.
• ASQ certification and audit participation experience are advantageous.