Senior Quality Design Engineer

Senior Quality Design Engineer role in Maple Grove, MN. This position focuses on ensuring that product designs meet quality and safety standards throughout the development process and collaborating with cross-functional teams to implement best practices in design assurance.

Base pay range: $/yr - $/yr

Salary: Up to $120,000

• Title: Senior Quality Design Engineer
• Employment Type: Direct-Hire
• Location: Maple Grove, MN 55369

• Bachelor’s Degree in Engineering or a related field;
  Master’s preferred.
• Minimum of 5 years of experience in design assurance within the medical device industry.
• In-depth understanding of design control and risk management principles.
• Proficient with FDA, ISO, and IEC regulations and standards.
• Proficient in statistical analysis software and methodologies.
• Strong communication skills and ability to work collaboratively in cross-functional teams.
• Demonstrated problem-solving abilities and attention to detail.

• Lead the design assurance activities and support product development through design verification and validation.
• Develop and execute risk management and design control documents, including DHF, DMR, and technical files.
• Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.
• Analyze testing data and prepare technical documentation for submissions to regulatory bodies.
• Oversee design reviews and provide constructive feedback to team members.
• Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.

• Medical insurance
• Vision insurance
• 401(k)