Apply now »

Senior Design Quality 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): 

Maple Grove, MN, US, 55311

 

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: 
We have an exciting opportunity for a Senior Design Assurance Engineer to assist with the development of the Wolf Thrombectomy Platform. The Wolf Thrombectomy Platform is a non-console and lytic-free platform designed with an innovative technology to rapidly capture and extract blood clots in arterial and venous systems.
The Senior DA Engineer will work cross-functionally to ensure the safety, quality and compliance of the device while delivering the highest quality product to the customer.  They will serve as the Quality team lead responsible for establishing and achieving design goals for quality, customer needs, business timelines, and manufacturability. To meet these goals the individual will utilize quality engineering methodologies and practices which meet BSC, customer, and regulatory requirements.
Your responsibilities include: 

  • Actively promote and participate in a cross-functional teamwork environment.
  • Participates in project teams to review and develop clear and concise user requirements, product specifications, plans, usability studies, and design verification and validation studies, risk management file and other relevant design control deliverables.
  • Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, Supplier Needs, and Manufacturing Input.
  • Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.
  • Establish and maintain Design History File and Design Input / Output documentation (Product Specification, Component Specifications, and Prints).
  • Actively participate in the Design Change process to ensure the proposed changes to the products are systemically and thoroughly analyzed and assessed
  • Support the verification, validation, and usability testing to meet or exceed internal and external requirements
  • Leads the development of and coordinates the execution and documentation of Design Validation and Verification activities.
  • Lead test method validation for design verification and validation test methods.
  • Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Coordinate and lead Root Cause investigations, corrective action determinations, and verification of effectiveness (CAPA) using proven quality tools and methodologies.
  • Supports product Post Market activities such as assessment of risk based on post market signals, field assessments, and post market surveillance plans and reports.

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

  • BS in Mechanical / Biomedical Engineering or related discipline or equivalent combination of education and experience to perform at this level
  • 4 years of experience in design assurance for new product development
  • Strong written/verbal communication skills
  • Demonstrated use of Quality tools and methodologies with an emphasis on Design Controls and Risk Management
  • Knowledge of key regulatory requirements, including ISO 14791 (Risk Management), 21 CFR 820 (US QS Regulation), ISO 13485 (Quality Management Systems), EU MDR,- and IEC 62366-1 (Usability)
  • Working knowledge and application of validation and statistical techniques to comply with associated regulatory requirements and internal standards.

Preferred qualifications:

  • Demonstrated experience developing and launching catheter-based medical devices
  • Experience leading Design Assurance and Quality System integration projects  
  • 1-2 years’ supervisory experience of technical personnel

#LI-Hybrid

 

 

Requisition ID: 528442

 

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: Compliance, Quality Engineer, Risk Management, Quality Manager, Medical Device, Legal, Engineering, Finance, Healthcare, Quality

Apply now »