Senior Quality Engineer Job
Additional Locations:
(n/a)
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.
Sr. Electrical (EE) Design Quality (DQA) Engineer
About the role:
Boston Scientific is a world wide and diverse company who puts patients first. Through this position, the ideal condidate will use their electrical experience to lead, develop, establish and maintain medical electrial systems (MES) for new product development (NPD) within the Urology Division of Boston Scientific (BSC).
Our team is all about building the future of the operating room for Urologists. As the industry leader in surgical kidney stone treatment, we are on a mission to empower physicians to treat more cases, more efficiently, with better outcomes; To help patients in need get back to their daily lives. As a Sr. EE DQA Engineer, you ll be at the heart of that mission to develop best-in-class products to bring advanced, safe innovations to the clinic. You will also be leading the effort to establish and maintain medical electrical systems (MES) for new product development (NPD) in partnership with the greatest minds in the entire medical device industry. Your contributions will directly impact patient care at a company widely regarded as being a quality leader in the medical device industry.
Your responsibilities include:
- Develop the Boston Scientific Quality System for New Product Development (21 CFR 820/ ISO13485) of MES products including Basic Safety and Essential Performance process (IEC 60601-1).
- Lead the DQA project team by working with Product Development Engineers (embedded within R&D) to review HW/SW systems and identify possible failure modes/risk control opportunities for these complex systems.
- Lead and guide other Design Quality Engineers to identify risks through coordinating with R&D during all phases of Electrical HW/SW design using Quality Assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
- Create and maintain risk management and usability documentation such as, Hazard Analysis, Design Failure Mode and Effects Analysis (DFMEA), Task Analysis and Fault Tree Analysis (FTA) incorporating 60601-1 principles.
- Create and/or review electrical DQA documentation as required.
- Lead DQA Communities of Practice (COP s).
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Support diversity and inclusion of initiatives within the company
- May perform other duties as directed
What we re looking for in you:
Minimum Qualifications
- BS in Electrical Engineering.
- 5 7 years of Medical device engineering experience, with experience in Medical Electrical Systems
- Strong communication and presentation skills.
- Competent with use of Microsoft Office Suite, Minitab Statistical Analysis software (or equivalent) and other electrical testing/simulation software.
- Travel approximately 10-15% of the time
Preferred Qualifications
- Understanding and practice of FDA, ISO, EUMDR and the medical device industry quality requirements associated with product development, design controls, product risk management and usability engineering.
- Working knowledge of US and International regulations including 21 CFR 820, is ideal, as well as the Medical Device Directive / Medical Device Regulation, EN ISO 13485, IEC 60601 and EN ISO 14971.
- MS in Electrical or Software Engineering strongly preferred.
- 7
years of medical device engineering experience preferred with knowledge experience with Medical Electrical Systems and Integrating Systems.
Requisition ID:
480462
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.
Estimated Salary: $20 to $28 per hour based on qualifications.
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