Design Assurance Engineer

Job Title : Design Assurance Engineer - Medical Device

Duration : 6+ Months (Possible extension)

Location : Maple Grove, MN 55311

Hybrid Role

Responsibilities :

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet client, customer, and regulatory requirements.
• Provides focused quality engineering support within new product development.
• Responsible for design control and risk management of next-generation medical devices.
• Uses clinical knowledge to influence how devices they are working on are tested and designed.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Independently, or as a member of a team, develops, directs, and executes plans for design control and risk management of complex projects.
• Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
• Demonstrates good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
• Demonstrates good working knowledge in pharmaceutics or combination regulatory requirements, 21 CFR 211 and ICH Quality Guidelines.
• Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team.
• Provides quality input (SME and / or independent reviewer) as required, at defined project / product / process milestones (e.g., design reviews, project design plans, design / process changes to existing product lines).
• Keeps up to date on all ISO / EN / FDA / MDR and other Product Development related regulatory requirements and relay this information to the Product Development group

Education / Experience :