We have an exciting opportunity for a Senior Design Assurance Engineer supporting Structural Heart projects within the Interventional Cardiology division. This position supports a major product category with high visibility which will provide the right candidate with excellent growth potential. Work with high-performance cross-functional development team to establish and maintain the design control and risk analysis required to bring novel technologies into clinical trials and commercialization.
Your responsibilities include:
Actively promote and participate in a cross-functional teamwork environment.
Leads the implementation and development of product risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
Leads/supports the determination and implementation of Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.
Leads the development of and coordinate the execution and documentation of Design Validation and Verification activities.
Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Lead/support implementation of reliability program for device implant and materials.
Demonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standards.
Perform regulatory standard assessments and support regulatory submissions to notified bodies.
Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables
What we’re looking for:
Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
3-5+ years of experience in design assurance, new product development or related medical device experience
Self-motivated with a passion for solving problems and a bias for action
Hands-on approach to product development
Strong communication skills (verbal & written)
Demonstrated use of Quality tools/methodologies.
Executive / senior industry position
Maple Grove , United States