Design Quality Assurance Engineer II

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 on a 12-month defined-term basis to join our team.

Job Purpose:

The Design Assurance Engineer is a quality engineer that directly supports medical device product development from concept through commercialization.  This individual will work with high-performance cross-functional development team to ensure safety, quality and compliance of launched products while continuously improving their commercial value. Working within NPD teams that utilize Agile approaches and practices.

Provides quality engineering support as part of a new product development team.  Develops, establishes, and maintains quality-engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support assigned departmental, functional, site, divisional and corporate quality goals, and priorities. Provides quality engineering support within technical development projects, new product development projects, sustaining existing product families, or system/services support.

Key Responsibilities:

• Working knowledge of Design Controls. Provide quality and compliance input to project teams for project decisions and deliverables (i.e. Design Change Analysis, Design Inputs, Design Outputs, Test Methods, Design Reviews, Design V&V, Usability Testing, SW Validation, Process Validation and Labeling).
• Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of field data and Risk Management.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Provide quality guidance to assure country specific compliance.
• Champion compliance to company policies, work instructions and SOPs.
• Fully conversant with validation techniques and associated regulatory requirements including analysis of customer feedback and complaints.
• Support effective quality assurance, process controls and metrics using data and statistical analysis to drive improvements and actions for manufacturing and assembly of products.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, supplier auditing and surveillance, design concessions, product CE marking and safety certification, customer complaint investigations, NCEPs, CAPAs, PIRs, Field Signals Evaluations and Field Actions.
• Support internal and external regulatory audits as required.

Education & Experience:

• Level 8 Honors Bachelors Degree in Mechanical, Electrical, Biomedical Engineering, or related degree.
• 2+ years experience with Medical Device engineering experience.
• Detailed understanding and working knowledge of US and International regulations including 21 CFR part 820, is required, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485 and EN ISO 14971.
• Travel approximately <10%
• Electrical Medical Device experience and working knowledge of IEC 60601 desirable
• Experience in design controls and development of DHF deliverables. Understanding of interdependencies between design documentation ranging from Hazard Analysis, Task Analysis, Design Requirements, Design Controls, Design Verification and Design Validation/Usability desirable
• Strong communication (oral and written) and presentation skills.
• Ability to collaborate and work on a global team.
• 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.
• Minitab Statistical Analysis software (or equivalent).

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.

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