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Design Quality Assurance Engineer II - Vascular and Interventional Oncology

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):  N/A

Location Details: This is a hybrid role based in Maple Grove, MN with the expectaion to be in the office up to 3 days per week.

 

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 Design Assurance Engineer II is a quality engineer that directly supports medical device product development through the product life cycle from concept through commercialization.  This individual will work with a high performance cross-functional team to ensure safety, quality and compliance of the launched products while continuously improving their commercial value. This position will focus on products for the Interventional Oncology and Vascular franchises.

Your responsibilities will include:

  • Apply sound, systematic problem-solving methodologies to resolve quality issues
  • Act as an effective team member in supporting quality disciplines, decisions, and practices
  • Work within a cross-functional team to identify and implement effective controls and support product development from concept through commercialization
  • Monitor field performance of recently launched and established medical devices against risk assessments
  • Support Post Market activities such as assessment of risk based on post market signals, field assessments
  • Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
  • Demonstrate good working knowledge and application of validation and statistical techniques in compliance with associated regulatory requirements and internal standards.
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Develop, update, and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints)
  • Generate, update, and maintain product risk management and Usability tools (e.g., Hazard Analysis, Fault Tree, FMEAs, Task Analysis)
  • Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input
  • Partner cross-functionally to identify and support value improvement efforts to support business goals

What we’re looking for in you:
Minimum requirements:

  • Bachelor’s degree in an engineering related discipline
  • 2+ years of experience in design assurance, new product development or related experience in a highly regulated industry 
  • Self-motivated with a passion for solving problems and a bias for action
  • Strong communication skills (verbal & written)
  • Demonstrated use of Quality tools/methodologies
  • Ability to effectively work and collaborate in a mixed onsite plus remote environment.
  • Travel up to 20% (domestic and international)

 
Preferred qualifications:

  • Medical Device industry experience 
  • ISO 13485, ISO 14971 and FDA Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
  • Experienced problem solver, capable of facilitating the problem-solving process
  • Adaptable and effective collaborator in a team environment or in self-directed work
  • Experience with design changes, complaint reduction, and corrective action 
  • Strong verbal, written communication skills, both technical and conversational
  • Decision making and negotiation skills, individually and within groups
  • Experience in managing multiple projects across multiple organizational disciplines

#LI-Hybrid

Requisition ID: 557396


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, Vascular, Compliance, QA Engineer, PLM, Healthcare, Legal, Engineering, Management

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