Design Assurance Engineer II

Additional Location(s): N/A

Diversity

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• 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.

About the role:

Boston Scientific is currently recruiting for a Design Assurance Engineer II in our Maple Grove MN location. This is an exciting opportunity to participate in development of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of BSC.

Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process. This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports. This role will be responsible for ensuring quality and compliance through product development and commercialization.

Your responsibilities will include:

• Participates in the implementation of new product design (NPD) Risk management (per ISO 14971)

• Including generation of Hazard Analyses, Design FMEAs, requirements traceability matrices, etc.

• Support verification, validation, and usability testing to meet or exceed internal and external requirements

• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

• Develop Design History File and work with RD for Design Input / Output documentation (Product Specification, Component Specifications, and Prints)

• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.

What we're looking for in you:

Required qualifications:

• Bachelor's degree in mechanical, electrical, biomedical engineering, or related discipline

• 2 years of experience in design assurance, new product development, or related medical device or regulated industry experience

• Working knowledge of US and International medical regulations including 21 CFR 820, Medical Device Directive / Medical Device Regulation, EN ISO 13485, and EN ISO 14971

Preferred qualifications:

• Experience with class III medical devices

• Experience with medical standards compliance

Requisition ID: 585237

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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 prohibited substance 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.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination.

Nearest Major Market: Minneapolis

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