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Senior Design Assurance Product Performance Engineer
2 months ago
Work mode: Hybrid
Onsite Location(s):
Maple Grove, MN, US, 55311
Additional Location(s): N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role:
We have an exciting opportunity for a Senior Design Quality Engineer supporting WATCHMAN 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, commercial experience, and perspective in the medical device industry. The Senior Design Quality Engineer will work with a high-performance cross-functional team to ensure safety, quality and compliance of WATCHMAN products to deliver the highest quality product to the customer.
Your responsibilities include:
- Functional lead who applies sound, systematic problem-solving methodologies in identifying, analyzing, prioritizing, communicating, and resolving quality issues.
- Facilitate cross-functional team to identify/implement effective controls and support product performance/development.
- Demonstrates sound working knowledge and application of risk management file.
- Assess, maintain, and update product trending (e.g. Risk Thresholds) and evaluate associated product risk management impact (e.g. Hazard Analysis, Fault Tree, FMEAs).
- Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Mentor for technical guidance for identifying and resolving quality issues.
- Acts as an effective leader/team member in supporting quality disciplines, decisions, and practices.
- Support submissions to notified bodies.
- Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Mentor cross functional team through product life cycle process; specifically, with respect to design control and risk management deliverables.
Minimum qualifications:
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field of study
- 5+ years’ experience in Design Quality or related medical device experience; or Master’s degree and 3 years’ experience
- Hands-on approach to product development
- Demonstrated use of Quality tools/methodologies
- ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
Preferred qualifications:
- Self-motivated with a passion for solving problems and a bias for action
- Ability to manage multiple priorities and work with ambiguity
- Strong communication skills (verbal & written)
