Job Description

Design Quality Engineer - Maple Grove, MN

Hybrid Schedule

Pay Rate: $45-50+ per hour

Qualifications:

• Bachelor’s degree with 5–8 years of experience, Master’s degree with 3–6 years, or PhD with 0–3 years.
• Experience in design control and risk management of next-generation medical devices.
• Background in pharmaceutical or combination products, with knowledge of 21 CFR 211 and ICH Quality Guidelines.

Responsibilities:

• Apply clinical expertise to guide device testing and design decisions.
• Develop, direct, and execute design control and risk management plans for complex projects, independently or in collaboration with cross-functional teams.
• Lead the development and implementation of product risk management tools, including Hazard Analysis, Fault Tree Analysis, and FMEAs.
• Provide quality input as a subject matter expert (SME) and/or independent reviewer at key project milestones (e.g., design reviews, project design plans, design/process changes).
• Promote and ensure compliance with company quality systems, business processes, health & safety standards, and applicable market/regulatory requirements.

Quality & Compliance Expertise:

• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Demonstrate proficiency in validation and statistical techniques to ensure compliance with regulatory requirements and internal standards.
• Maintain expertise in pharmaceutical and combination product regulations, including 21 CFR 211 and ICH Quality Guidelines.
• Stay current with ISO, EN, FDA, MDR, and other product development–related regulatory requirements, and communicate updates to the Product Development team.

Culture & Leadership:

• Foster a culture of quality-driven, patient-centric product development and customer satisfaction.

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