Design Assurance Engineer II

Hopkins, MN | Contract-to-Hire | $30-45/hr

Konik is partnering with a local pharma/med device manufacturer seeking to add a Design Assurance Angineer to work with the new product team.  They are seeking a Design Assurance Engineer II to lead quality engineering activities for product development and design changes, ensuring quality, reliability, and compliance from conception to commercialization. This role involves managing risk, driving design quality, and supporting regulatory compliance for mechanical product designs.

Design Assurance Engineer Responsibilities:

• Oversee mechanical product design quality, reliability, and regulatory compliance.
• Lead design control deliverables and risk management activities for development projects and product releases.
• Identify and resolve potential design quality issues.
• Develop and execute risk management files and reports.
• Create and manage release testing plans for new products.
• Ensure DHF and DMR integrity and compliance, addressing any gaps collaboratively.
• Support system development, design test validation, and verification/validation activities.
• Partner with manufacturing teams to qualify processes for new products and changes.
• Assist in internal and external audits, complaint investigations, and significant quality-related investigations.
• Maintain strong cross-functional and external partnerships to drive success.

Design Assurance Engineer Qualifications:

• Bachelor’s degree in Mechanical Engineering, Material Science, Biomedical Engineering, or a related field.
• Minimum of 3 years of relevant experience in the medical device or related industry.
• Knowledge of GMP, ISO, QSR, and applicable regulations preferred.
• Strong statistical data analysis and project management skills.
• Excellent verbal and written communication; ability to educate and collaborate across teams.
• Self-motivated, customer-focused, and capable of managing multiple priorities.

Preferred Skills:

• Experience with Design for Six Sigma and Critical to Quality processes.
• Background in sterile pharmaceutical and drug-device combination products.
• Participation in audits and experience partnering with external organizations.
• ASQ certification is a plus

Benefits:

• Health & dental insurance
• Paid holidays
• MN Earned Sick & Safe Time
• Weekly paychecks
• Paid Time Off (PTO) for long-term contractors
• 401k for long-term contractor

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Konik is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as a qualified individual with a disability, or any other protected class status.

Konik has been creating impactful relationships between technical talent and employers for more than 50 years. Konik has specialized in placing professional, qualified personnel in Minnesota and western Wisconsin businesses since its inception, and maintains a strong commitment to customer service.