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Senior Design Quality Assurance Engineer Job

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Minnetonka, MN, US, 55343

Additional Location(s): US-MN-Plymouth; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove; US-MN-Minnetonka

 

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.

 

 

About the role:
 

The Senior Design Quality Assurance Engineer develops, establishes, and maintains quality engineering methodologies, systems, and practices which meet BSC, customer and regulatory requirements. The individual in this role will serve as a Quality representative to improve awareness, visibility, communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. They will provide focused quality engineering support within new product development, operational, or system/services support. This position interfaces with cross functional teams to complete sustaining projects, design control deliverables, and activities to ensure Prosthetic Urology products meet evolving standards in the European Union (EU) where applicable. This role ultimately provides quality engineering support within sustaining exiting product families, continuous improvement product development projects, or ongoing quality system / post market support.

 

 Your responsibilities include:

  • Lead and supports new product development, as well as the sustaining efforts of Prosthetic Urology products (eg. EN 13485 / CFR820)
  • Own Risk Management planning, reporting and the development of critical risk documentation in compliance with Boston Scientific procedures and external standards (e.g. EN 14971)     
  • Owns Usability Engineering and planning documentation (e.g. EN 62366/ISO 62366)
  • Updates and maintains Design History Files to state-of-the-art including Post Market Surveillance activities
  • Provide quality and compliance support during regulatory audits and responses to government agency questions
  • Lead CAPA efforts, and apply sound, systematic problem-solving methodologies identifying, prioritizing, communicating, and driving resolution of quality issues (e.g., 5 why’s analysis, Is-Is Not analysis, and Six Sigma problem solving methodologies).

 
 

Minimum Qualifications:

  • Minimum of a bachelor’s degree in science, engineering or other related technical discipline
  • Minimum of 5 years of experience in medical devices or another related highly regulated industry
  • Experience with Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)

 

Preferred Qualifications:

  • Experience with electrical systems and software for medical devices
  • Demonstrated in-depth familiarity with the FDA, ISO, MDD, and the medical device industry quality requirements associated with product design/development and product risk management
  • Knowledge of US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, and EN ISO 14971

 

 

 

Requisition ID: 527118

 

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.

 

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

Job Segment: Medical Device, QA Engineer, Senior Quality Engineer, Medical Device Engineer, Quality Engineer, Healthcare, Engineering

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