Design Assurance Quality Engineer

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.

Purpose Statement

Boston Scientific Interventional Cardiology/Vascular team is seeking a Design Quality Engineer II to help advance our product portfolio. In this role, you will collaborate across functions to ensure device safety, quality, and regulatory compliance, delivering exceptional products to our customers. As a key member of the Quality team, you will support the sustaining engineering activities for Atherectomy and Accessory devices within the Rotalink and Cork Accessories team. You will apply robust quality engineering methodologies that align with Boston Scientific, customer, and regulatory standards.

Key Responsibilities

General

- Be a part of extended project team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.

- Develops understanding of Design Controls, Risk Management and Usability for Medical Devices.

- Supports departmental, functional, and divisional Design Quality goals and priorities.

- Executes methodologies to meet individual and team objectives effectively.

- Execute methodologies such as Statistical Analysis, Risk Management, and Root Cause Analysis in support of project activities.

- Ensure adherence to the quality systems and Design Assurance SOPs and Boston Scientific’s Product Life Cycle Process (PLCP).

- Apply critical thinking and engineering analysis to solve problems.

- CAPAs, VIPs, and regulatory requirement changes.

- Analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data.

Required qualifications

- Minimum of a Honours bachelor’s degree (Level 8) in engineering (Biomedical, Mechanical, Electrical, etc.) or equivalent fields of study.

- 2+ years of experience in design assurance or a related field, or a combination of education and experience to perform at this level.

- Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems).

Preferred qualifications

- Understanding of Quality tools and methodologies with an emphasis on Design Controls and Risk Management.

- Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.

- Strong technical knowledge, problem-solving abilities, collaborative mindset, and effective communication skills.

- Experience with Post Market Surveillance, EU MDR, and IEC 62366-1 (Usability).

- Ability to work independently and as part of a team.

Requisition ID: 615509

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 (NYSE: BSX) 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

Job Segment: Quality Engineer, Biomedical Engineering, PLM, Risk Management, Compliance, Engineering, Management, Finance, Legal

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