Design Quality Assurance Engineer II

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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 (Cutting Balloon PDP) on apermanent basisto join our team.

Job Purpose:

We have an excellent opportunity for a Design Quality Assurance Engineer II (Cutting Balloon PDP) to join our team in Boston Scientific. As part of the Design Quality Assurance team, a key role will be to demonstrate commitment to the Quality Policy (patient safety and product quality) by executing sound quality practices and maintaining an effective quality system. In addition, the team member will support the application of Design Controls in projects, initially supporting a Product Development Process (PDP) project.

The Design Quality Assurance team supports a wide product portfolio including drug eluting therapies (drug-coated stents and drug-coated balloons), balloon dilatation catheters and cutting balloons for Interventional Cardiology. The successful candidate may flex across projects to support quality, compliance, material continuity, and design Value Improvement Projects (VIPs), ensuring that all design changes are compliant to associated regulations and procedures.

Key Responsibilities:

- Effective understanding of requirements and procedures that govern medical device Design Control.
- Understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
- Develop and maintain the PDP Design History File, supporting deliverables including design inputs, design outputs, design verification, design validation, useability risk management and design reviews.
- Provide design quality support in the resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
- Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations team environments to provide technical and quality systems input.
- Draws conclusions and makes appropriate decisions from test data using excellent analytical and problem-solving abilities.
- Ownership of design change projects including scoping, assessment and implementation.
- Drive updates to documents within the Risk Management File, such as the Hazard Analysis, Task and Use Error Analysis and Design FMEA.
- Ensure and maintain regulatory compliance with appropriate guidance documents such as company SOP/WI's and EU/FDA/Global guidelines.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

Education & Experience :

- Min 3 years experience industry experience; Design Assurance experience would be an advantage
- Experience in areas such as new product development, design control, risk management, design change, and standards compliance (to regulatory requirements) would be an advantage
- Strong technical capabilities, communication and collaboration skills, and ability to adapt and flex across projects
- Proven ability to work well both as part of a team and individually.
- Is enthusiastic and fully motivated to develop their career, to demonstrate best practices in line with the department and site objectives and continually seeks to drive improvements in product and process quality.

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

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 TalentAcquisitionIre@bsci.com

Job Segment: QA Engineer, Quality Assurance, QA, Medical Device Engineer, Quality Engineer, Engineering, Quality, Technology

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