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Diversity – Innovation – Caring – Global Collaboration – Winning Spirit – Caring – 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.
Design Quality Engineer II
About the role:
This position is an opportunity to work for a world wide and diverse company who puts patients first. Through this position, the ideal condidate develops, establishes and maintains quality engineering methodologies, systems, and practices which meet Boston Scientific (BSC), customer, and regulatory requirements. Serves as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. Provides focused quality engineering software support within new product development, operational, or system/services support.
Your responsibilities include:
- Working within a team of Product Hardware, Firmware, and Software Engineers (embedded within R&D and Quality Assurance groups).
- Actively contributing to all aspects of Hardware, Firmware, and Software Quality Assurance activities in an FDA/EUMDR-Regulated Class II Medical Device Software environment including interconnected systems.
- Support the design, development, and test of hardware, firmware, and software, used in Boston Scientific Endoscopy product lines during their entire Development Life Cycle, from the Requirements gathering phase to the Retirement phase.
- Participate in product system and sub-system level design reviews with focus on hardware and firmware evaluation, product risk mitigation, and other required Risk Management activities.
- Participate in software design reviews with focus on unit test, regression tests, test automation, software architecture, cybersecurity, SOUP evaluation and other areas of related to software risks and Risk Management activities.
- Support the creation and execution of validation protocols to perform sub-system and system level testing of our products and report any issues discovered.
- Creation and review of risk management documentation such as, Design Failure Mode and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA).
- Contribute to the development of software safety classifications / level of concern rationale.
- Creation and review of all medical device software documentation including cyber security assessments such as Data Protection, Privacy, Security Assessments etc.
- Creation and review of software, mechanical and hardware DQA documentation as required.
- Become a Subject Matter Expert (SME) for all firmware and software DQA requirements for the products supported.
- Support all aspects of DQA activities during internal and external audits, as needed.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- May perform other duties as directed
What we’re looking for in you:
- BS in Electrical, Computer, or Software Engineering (with significant EE coursework).
- Minimum of 3-5 years of Medical device engineering experience, with experience in Medical Device Software and integrating systems.
- Working knowledge of the FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management, usability engineering and medical device software.
- 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.
- Strong communication and presentation skills.
- Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent), Linux operating systems.
- Travel approximately 10-15% of the time
- MS in Electrical, Computer, or Software Engineering (with significant EE coursework) strongly preferred.
- 5+ years of medical device engineering experience preferred with 2+ years’ experience with Software a medical device experience.
- Familiarity with IEC 60601 family and EN 62304 preferred
Requisition ID: 477977
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!
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why 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 maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.