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.
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.
Boston Scientific is committed to providing reasonable accommodations for applicants and employees with a disability.
Should you require a reasonable accommodation during the recruitment process, please email