Senior Design Quality Engineer

Additional Location(s): Canada-ON-Mississauga; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove

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 Senior Design Assurance Engineer position will work on EP Integration projects, specifically supporting Design Controls under the direction of the Design Control Workstream lead. This position ensures that during the integration of products and Design Control quality system processes, the product and processes remain safe, of high quality, and compliant with regulatory requirements.  
Your responsibilities will include:

• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Acts as an effective team member and mentor in supporting quality disciplines, decisions, and practices
• Support Design Assurance activities as related to Risk Management remediation, Design Control Quality System integration, and other DA related integration priorities
• Support Post Market activities, as necessary, of risk based on post-market signals
• 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 tools (e.g., Hazard Analysis, Fault Tree, FMEAs)
• Partner with R&D to determine and implement Design Controls based on Risk Management, Customer Needs, and Manufacturing Input.

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

• Bachelor’s degree and 5 years or Master’s degree and 3 years of experience in design assurance, new product development, or related medical device experience. (Degree in an engineering discipline or related field of study.)
• Self-motivated with a passion for solving problems and a bias for action
• Hands-on approach to product development
• Strong communication skills (verbal & written)
• Demonstrated use of Quality tools/methodologies
• ISO 13485, ISO 14971, and Quality System Regulations understanding with a focus on Design Controls and Risk Analysis
• Ability to travel up to 10%

Preferred Qualifications:

• Quality integration experience 
• Boston Scientific experience
• Risk Management and ISO 14971 experience
• Proven ability to influence without authority
• Ability to effectively work and collaborate in a mixed onsite + remote environment

 

 

 

Requisition ID: 604589 

Minimum Salary: $ 82600 

Maximum Salary: $ 156900 

 

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-term incentives (subject to plan eligibility and other requirements).

 

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

 

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