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 Senior Design Quality Assurance Engineer on a permanent basis to join our team.
Job Purpose:
We have an excellent opportunity for a Senior Design Quality Assurance Engineer 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.
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 will lead projects related to the drug-coated balloon product line and will have supervision responsibility within their reporting structure - providing coaching and mentoring support including assignment and oversight of small to medium projects within the sustaining organization.
The candidate will lead 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:
- In-depth understanding of requirements and procedures that govern medical device Design Control.
- In-depth understanding of Design Assurance requirements to ensure project deliverables comply with all internal and regulatory requirements.
- Provide design quality leadership 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.
- Lead design change projects including scoping, assessment and implementation, through a combination of individual contribution and providing direction to team members
- Lead 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.
- Support internal and external regulatory audits as required.
- Provide support and direction for post market surveillance activities, such as Field Signal Evaluations, assessment of field product performance, NCEPs, Periodic Safety Update Reports (PSURs) and Q&A from regulatory authorities.
- Provide coaching and development support within their reporting structure, including assignment and oversight of small to medium projects within the sustaining organization.
Education & Experience:
- NFQ Level 8 qualification in a STEM discipline
- Min 6 years experience industry experience; Design Assurance experience would be preferable
- Experience in areas such as design control, risk management, design change, and standards compliance (to regulatory requirements)
- Strong leadership, problem-solving, technical capabilities, communication and collaboration skills
- 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.
- Interested in coaching and developing team members
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!
To search and apply for open positions, visit: https://bostonscientific.eightfold.ai/careers
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 [email protected]
