Design Assurance Engineer II
Location
Maple Grove, MN | United States
Job description
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 Design Assurance Engineer supporting WATCHMAN projects within the BSC’s Cardiology division. WATCHMAN continues to be an exciting growth driver for BSC. In a hybrid work mode, the Design Assurance Quality Engineer II provides quality engineering support to operations, product development and sustaining projects for current products on the market. The Design Assurance Quality Engineer II will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. This Design Assurance Quality Engineer II will serve as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals and priorities. The Design Assurance Quality Engineer II will provide quality engineering support within technical development projects, sustaining existing product families, or system/services support.
Your responsibilities include:
- Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews.
- Understand and support linkage of field data and Risk Management
- Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
- Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
- Provide quality guidance to assure country specific compliance.
- Champion compliance to company policies, work instructions and SOPs.
- Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
- Support internal and external regulatory audits as required.
Required Qualifications: - Minimum of a Bachelors Degree
- Minimum of 2 years of risk management or related experience
- Medical device experience
- Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent).
Preferred Qualifications:
- MS degree preferred
- Focus on detailed work with emphasis on accuracy and completeness
- Excellent organizational and planning skills; drives for results
- Strong communication (oral and written) and presentation skills
- High energy problem solver capable of driving items to closure
- Ability to collaborate and work on a global team
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