Apply now »

Principal Engineer - Design Quality Assurance (Urology & Pelvic Health) 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): 

Maple Grove, MN, US, 55311

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

 

 

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.

 

The Principal Engineer - Design Quality Assurance  (Urology & Pelvic Health) is an experienced professional with wide-ranging expertise in Quality Engineering for medical devices including design controls, risk management, usability, test method development, post-market surveillance, continuous Improvement, and problem solving. The individual in this role will also provide coaching to cross-functional project teams and implementation guidance for best practices for design quality.

 

Your responsibilities will include:

 

Project Support: 

  • Develops solutions to complex and diverse technical problems, which require the regular use of ingenuity and creativity
  • Provides in-depth and complex data/problem evaluation and analysis
  • Exercises judgment within broadly defined practices and policies in selecting methods, specialized techniques, and evaluation criteria for obtaining results
  • Provides quality and compliance input and coaching for product development and/or post market product sustaining activities, such as design changes, design concessions, product CE marking and safety certification, customer complaint investigations, NCEPs, CAPAs, PIRs and Field Actions
  • Leads CAPA efforts, and applies sound, systematic problem-solving methodologies by 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)

 

Product Support:

  • Champions franchise initiatives to improve product performance or value
  • Monitors data to identify trends or signals that will affect risk level or business continuity
  • Champions teams using DMAIC principles to address product and process opportunities

 

Quality System Champion:

  • Interfaces with senior management on significant matters, often requiring the coordination of activity across organizational units
  • May lead specialized technical project teams which have a broad impact on the company utilizing cross-functional resources
  • Acts as division representative on cross-divisional projects defining the quality system(s)
  • Provides technical leadership to business units.
  • Advise management on potential improvements or enhancements to quality systems and processes in the company
  • Support development, implementation, and training of corporate quality initiatives

 

Audit Support:

  • Supports internal and external regulatory audits 

 

Minimum Qualifications:

  • Minimum of a bachelor’s degree in science, engineering, or other technical discipline 
  • Minimum of 8 years of engineering experience (medical devices or other high regulated industry)
  • Demonstrated experience delivering presentations on complex quality-related issues and topics
  • Experience Microsoft Office Suite, and Minitab Statistical Analysis software (or equivalent)
  • Ability to travel up to 15%

 

Preferred Qualifications:

  • Experience working with cross-functional teams (regulatory, R&D, and clinical
  • Experience working with electrical and software for medical devices
  • In depth familiarity with the FDA, ISO, MDD and the medical device industry quality requirements associated with product development, design controls, and product risk management.
  • Demonstrated experience working with US and International regulations including 21 CFR, 820, 210, 211, and 11 is required, as well as the Medical Device Directive, EN ISO 13485, EN ISO 14971, IEC 60601, and EN 62366.

 

Requisition ID: 527119

 

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: QA Engineer, Medical Device Engineer, Quality Engineer, Six Sigma, Engineer, Engineering, Management

Apply now »