Design Quality Assurance Engineer Ii

Overview
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Design Quality Assurance Engineer II
role at
Boston Scientific
.
We are seeking a Design Quality Assurance Engineer II on a permanent basis to join our team.
This is an exciting opportunity to support the new Renal Denervation program within BSC's Cardiology division, with high visibility and growth potential 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 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
Required Qualifications
Minimum of a Bachelor's 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
Understanding of ISO 13485 / Quality System Regulations and ISO 14971 / Risk Management
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.
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
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At Boston Scientific, we recognise that nurturing a diverse and inclusive workplace helps us be more innovative.
It is essential in advancing science for life and improving patient health.
We stand for inclusion, equality, and opportunity for all.
By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve.
Boston Scientific is proud to be an equal opportunity and affirmative action employer.
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
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