Design Assurance Engineer III

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

Boston Scientific is seeking a highly motivated, experienced Design Assurance Engineer III on a permanent basis to join our team.

Job Purpose:

We have an excellent opportunity for a Design Assurance Engineer to join our team in Boston Scientific in a permanent role. As part of the Design 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 team member will support the application of Design Controls in projects focusing on quality, compliance, material continuity, and Value Improvement Projects (VIPs), ensuring that all design changes are compliant to associated regulations and procedures. In addition, the team member will support Post Market Surveillance activities such as monitoring product performance in the field and monthly signals, completing periodic safety update reports and improving the monitoring and trending processes.

The Design Assurance team supports multiple products in the Peripheral Intervention division.

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.
• 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, Operations and Post Market Teams (CIS, CMC and Trending) in a project team environment to provide technical and quality systems input.
• Development and execution of protocols and reports as part of Design Verification and Stability activities through the life cycle of the product.
• 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 Analysis and Design FMEA.
• Work with cross functional, global teams to support execution of ICH stability studies for development, commercialisation and post-approval commitments of drug-device combination products.
• Development and execution of stability plan, protocols and reports for drug-device combination products as part of Design Verification activities through the life cycle of the product.

Education & Experience:

• Level 8 Honours Bachelor Degree (240 credits) qualification in a STEM discipline
• Minimum 5-years Design Assurance Engineering experience 
• Experience in areas such as Post Market Surveillance, complaints, design control, risk management, design and process change, and standards compliance (to regulatory requirements) is key
• Strong technical capabilities, communication skills, teamwork abilities and initiative
• Proven ability to work well both as part of a team and individually.

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 TalentAcquisitionIre@bsci.com