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Principal Design Assurance Systems Engineer

Work mode:  Hybrid
Onsite Location(s): 

Maple Grove, MN, US, 55311

Additional Location(s):  N/A

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 Principal Design Assurance Engineer will interface with R&D on development of medical electrical equipment (Circulator Support System) with specific focus on mechanical and electrical elements including development of risk analysis and planning, test plans/reports, and implementation of design processes with compliance to company procedures. Represent DA for systems new product development.
 
Provides focused quality engineering leadership on new product development design assurance.  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. Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality related issues.
 
Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.
 
Your responsibilities include:

  • Leads or participates in the implementation of new product design (NPD) design assurance: Risk management (per ISO 14971), User and Design FMEAs, requirements traceability matrices, design verification and validation, Design Change Analysis Forms, etc. Utilize statistical analysis techniques to determine product acceptance.
  • Leads or participates in core team meetings, CCB, and MRB meetings.  Interfaces and manages work with other quality organizations such as biocompatibility, microbiology, sterility, and manufacturing/ops requirements.  Thorough understanding of design controls.
  • Participates in design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. Ensure customer requirements are met by incorporating engineering principals in robust design and in design for manufacturability. Actively participate in all aspects of Design Control
  • Design, develop, refine, and validate test methods and inspection procedures.  Guide/author design verification and design validation protocols and reports.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead and participate in product failure investigations and root cause analysis.
  • Provide technical guidance and training to team members in statistical analysis techniques, experimental design and other QA Engineering areas of expertise.
  • Provide technical guidance and training to other department members and engineering staff in statistical analysis techniques, experimental design, data analysis, and product/process verification and validation.
  • Directly interface with people performing internal and external audits.
  • interface with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support certification / recertification activities for US, European and other markets.
  • Consult with and provide guidance to Quality Technicians and other Quality Engineers.  Work to ensure compliance with corporate quality systems requirements.
  • Provides leadership role on championing departmental or cross-functional engineering initiatives.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Understanding of technologies incorporated into design.

 
What we’re looking for in you:

Required qualifications:

  • Bachelor’s degree in Engineering
  • 7+ years of related experience
  • Understanding of electrical safety standards IEC 60601
  • Experience with reliability testing
  • Understanding of configuration management
  • Demonstrated use of Quality tools/methodologies
  • Strong written/verbal communication skills.

 
Preferred qualifications:

  • Previous R&D experience
  • Strong knowledge of QSR and ISO standards
  • BS in Electrical Engineering preferred
  • Medical device experience
  • ASQ certification

Requisition ID: 585016


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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