Design Assurance Team Leader
Boston Scientific Corporation
Location
Mississauga, ON | Canada
Job description
Work mode: Hybrid Preferred, Remote Considered
Onsite Location(s): Mississauga, ON, CA
Additional Locations: Canada-ON-Mississauga; Canada-ON-Toronto
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 At the Boston Scientific Access Solutions Site in Mississauga, ON we are looking for a Design Assurance Team Leader who has experience leading a team of Design Assurance Engineers, supporting new product development (NPD) and leading risk management activities. We are looking for a highly motivated individual who is ready to support and develop a team of technical personnel
Your responsibilities will include: - Provide focused quality engineering support within product development, operational, or system/services support for electrophysiology products.
- Uses clinical knowledge to influence NPD teams and how devices are tested and designed.
- Work with development teams and applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Review and communication of post market and field signals through review of complaints and quality trends.
- Leads the implementation and development of risk management tools (i.e. Hazard Analysis, Fault Tree, FMEAs).
- Generate, review, and approve documentation in the Windchill document control system.
- Recommend updates to procedures when indicated to reflect revisions to standards.
- Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements for medical devices.
- May conduct training on design assurance concepts and tools.
- Act as mentor to engineers for development, building efficiency and increasing their effectiveness to the overall team.
- Promotes and influences compliance to BSC’s quality, business and health & safety systems and market/legal regulations.
- Serve 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.
- Apply sound systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Will manage a team of approximately 6 Design Assurance Engineers.
- May be required to travel, domestically or internationally.
- Other duties as required.
Required qualifications: - Bachelor’s degree in Electrical Engineering, Mechanical Engineering, or Biomedical Engineering
- 6+ years of medical device work experience
- Leadership of technical team including leading and developing other leaders
- Knowledge of ISO 13485, IEC 62366-1, IEC 60601 standards
- Ability to travel domestically and internationally
- Work experience must include:
- Design Controls, Design Changes and DCAFs
- Knowledgeable of ISO 14971 and risk management tools
- Design Verification and Validation
- Test method validation
- Windchill document control system
- Non-Conforming Events and CAPAs using eCAPA system
Requisition ID: 577935
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!
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