About the position
The Design Quality Assurance Engineer II supports a major product category with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional Sustaining Engineering team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. Products transferred to Sustaining Engineering (SE) include internally developed products, Sourced Finished Medical Devices, and acquired products. This position will be located in Maple Grove, MN and will provide key project support for design changes, market expansion, product performance monitoring, risk assessments, and cost reduction activities. The SE Design Quality Assurance engineer works in close partnership with Operations, Project Management, Regulatory, and Research & Development and focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.
Responsibilities
- Actively promote and participate in a cross-functional teamwork environment.
- Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed.
- Maintains product risk management documentation (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Supports product Post Market activities such assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports.
- Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
- Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Demonstrate good working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.
- Perform regulatory standard assessments and support regulatory submissions to notified bodies.
- Maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
- Collaborate with cross-functional new product development team to facilitate design ownership transfer to SE team; specifically, with respect to design control, risk management, and usability deliverables.
Requirements
- Bachelor's degree in an Engineering discipline or related field of study
- 2-4+ years of experience in design assurance, sustaining engineering, or related medical device experience
- Self-motivated with a passion for solving problems and a bias for action
- Hands-on approach to project work and collaboration
- Strong communication skills (verbal & written)
- Demonstrated use of Quality tools/methodologies.
- ISO 13485, ISO 14971 and Quality System Regulations understanding with a focus on Design Controls and Risk Management
Nice-to-haves
- International cross-functional collaboration
Benefits
- 401k
- 401k_matching
- dental_insurance
- health_insurance
- life_insurance
- vision_insurance
- paid_holidays
- paid_volunteer_time
- tuition_reimbursement
- professional_development
