Sr Design Quality Engineer - Sustaining Engineering

Recruiter: Spencer Gregory Hale

 

 

Senior Design Quality Engineer – Sustaining Engineering

 

About the role:

The Design Quality Engineer supports major products with high visibility, providing the right candidate with excellent growth potential.  Work with high-performance cross-functional Sustaining Engineering (SE) team to ensure safety, quality and compliance of launched products while continuously improving their commercial value through end-of-life. Products transferred to SE include internally developed products, Sourced Finished Medical Devices, and acquired products. SE Design Assurance engineer works in close partnership with Research and Development and focuses on protecting the design intent of a product to meet safety, efficacy, regulatory, and business requirements.

 

Your responsibilities include:

• 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 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.
• 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).
• Mentor cross functional team through product development process; specifically, with respect to design control and risk management deliverables
• Potential for supervisory responsibility

 

What we’re looking for in you:

Minimum qualifications:

• Bachelor’s degree in an Engineering discipline or related field of study
• 5+ years of experience in design quality/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.
• ISO 13485, ISO 14971, EU MDR, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis

 

Preferred qualifications:

• MBA or advanced degree in science
• Previous supervisory experience
• Experience with technology acquisition & integration
• International project support/coo