Systems Design Assurance Principal Engineer

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:
Boston Scientific is currently recruiting for a Systems Design Assurance Principal Engineer in our Maple Grove, MN location.  This is an exciting opportunity to participate in development of single use devices for use with medical electrical equipment/systems (MEE) within Interventional Cardiology (IC), which is a rapidly growing division of Boston Scientific.    

The Systems Design Assurance Principal Engineer 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. This role will be responsible for ensuring quality and compliance through product development and commercialization.

Your responsibilities will include:

• Lead or mentors the project team in the execution of deliverables such as Design and Development Planning, Risk Management, Design Verification and Validation, Usability Validation plans, Design Review, Field Assessment, Design Change, and NCEP/CAPA/PIR
• Effectively communicates within project team, across functions, and elevates issues above the project team as appropriate
• Develops solutions to complex and diverse technical problems which require the regular use of ingenuity and creativity. Analysis of situations or data requires an in-depth evaluation of various factors
• Influences cross-functional plans, guides overall project strategy, knows when to solicit feedback, and facilitate project decisions
• Builds quality into all aspects of work by maintaining compliance to all quality requirements, defending work of their team, as well as supports internal external regulatory audits
• Participates as a division representative in cross-divisional projects defining the quality system and may advise management on potential improvements to the quality systems and processes
• Supports functional and divisional design quality goals and priorities

What we're looking for in you:
Required qualifications:

• Bachelor’s degree in mechanical, electrical, biomedical engineering, or related discipline 
• 7+ years of related experience in design assurance, new product development, or related medical device or regulated industry experience
• Understanding of electrical safety standards IEC 60601
• Experience with reliability testing
• Demonstrated use of Quality tools/methodologies
• Strong written/verbal communication skills.

Preferred qualifications:

• Experience with class III medical devices
• BS in Electrical Engineering 
• Previous R&D experience
• Strong knowledge of QSR and ISO standards
• Medical device experience
• ASQ certification
   

 

 

 

Requisition ID: 604478 

Minimum Salary: $ 99100 

Maximum Salary: $ 188300 

 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

 

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

 

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long