Design Quality Assurance Engineer II

Design Quality Assurance Engineer II

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.

Advancing possibilities for a brighter tomorrow

We are seeking a Design Quality Assurance Engineer II on a permanent basis to join our team.

Job Purpose:

This is an exciting opportunity for a Design Quality Assurance Engineer II to join a cross-functional team on the new Renal Denervation business within BSC's Cardiology division. This position will support the significant new Renal Denervation acquisition integration and product development programs with high visibility, which will provide the right candidate with excellent growth potential, acquisition integration experience, and broad perspective in the medical device industry.

The engineer will provide quality engineering support to acquisition integration, product development and sustaining projects for current clinical products and future commercial products. They will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. The Design 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.

At Boston Scientific, we value collaboration and synergy.

Key Responsibilities:

• Support the verification, validation, and usability planning and testing to meet or exceed internal and external requirements
• Develop, update, and maintain Design History File and work with R&D for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
• Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
• Support regulatory submissions to notified bodies.
• Develop, update, and maintain product and/or software risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs)
• Develop, update, and maintain the usability file: plan, participate in usability assessments, and generate/update usability documentation
• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues, with guidance/collaboration of the team

Preferred Education & Experience:

• Required Qualifications:
• Minimum of a Bachelors Degree in Mechanical, Electrical or Biomedical Engineering, or equivalent (minimum NFQ Level 8 qualification).
• Minimum of 3 years of experience in design assurance, quality, or related medical device or regulated industry experience
• Self-motivated with a passion for solving problems and a bias for action.
• ISO 13485/ Quality System Regulations, ISO 14971/Risk Management understanding
• Strong communication skills (verbal & written) and presentation skills
• Preferred Qualifications:
• Medical Electrical Equipment, Cybersecurity and Software design controls understanding
• Focus on detailed work with emphasis on accuracy and completeness
• Excellent organizational and planning skills; drives for results
• High energy problem solver capable of driving items to closure
• Ability to collaborate and work on a global team with peers in R&D, Process Development, Manufacturing and other groups.

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!