Design Assurance Manager - Mississauga, Canada - Boston Scientific Corporation
Description
Design Assurance Manager:
- Remote Eligible: Hybrid
- Onsite Location(s): Mississauga, ON, CA
Additional Locations: Canada-ONMississauga; Canada-ONToronto
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.
About the role
At the Boston Scientific Access Solutions Site in Mississauga, ON we are looking for a Design Assurance Manager who has experience with the new product introduction (NPI) process and leading activities related to risk management.
We are looking for a highly motivated individual who is ready to support and develop a team of technical personnel.
_This opportunity is a 12-month contract._
Your responsibilities will include:
- Provide focused quality engineering support within product development, operational, or system/services support for electrophysiology products.
- Work within a development team to identify and implement effective controls to support the development, qualification, commercialization, and sustaining activities of products to meet or exceed internal and external compliance requirements.
- Provide review of post market and field signals through review of complaints using Trackwise and SAP systems.
- Design, integrate and evaluate quality assurance process sampling systems, procedures and statistical techniques using Matlab; designs, qualifies, and/or specifies inspection and testing mechanisms and equipment such as Griffin Robot.
- 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 quality assurance concepts and tools.
- Act as mentor to junior engineers to build efficiency and increase their effectiveness to the overall team.
- Interface with all other engineering components within the company and with customers and suppliers on quality related issues.
- 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.
- Will manage two leaders, with a team of 20.
- 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
- 7+ years of relevant work experience
- Leadership of technical team including leading and developing other leaders
- Work experience must include:
- Design Controls, Design Changes and DCAFs
- Experience with Risk Management and FMEAs
- Complaint investigations and trending using Trackwise and SAP systems
- Design Verification and Validation
- Test method validation of equipment including Griffin Robot
- Windchill document control system
- Non-Conforming Events and CAPAs using eCAPA system
- Single use devices (electrophysiology catheter and Orion catheter)
- Statistical techniques using Matlab.
Preferred qualifications:
- Master's degree and Clinical background
- Experience in the medical device industry
What we have to offer:
- Hybrid working model for many roles combining onsite and remote work, paired with flexible working hours.
- A strong commitment to mental health and wellbeing, including a companypaid meditation app, meditation rooms in some buildings, fully trained Mental Health First Aid staff members, and weekly yoga/HIIT/Pilates/mindfulness online professionallyled classes for all employees.
- Headquarters based roles offer functional outdoor spaces (bring your laptop to one of multiple wifi connected outdoor patios to work) and access to a beautiful ravine trail system for lunchtime walks.
- Employer subsidized gourmet, highquality, healthy meals available onsite, freshly delivered multiple times a week.
- Strong senior leadership commitment to Inclusion and Diversity; many opportunities to join I&D committees and spearhead I&D initiatives; employerhosted roundtables with external experts, guest speakers and workshops/celebrations.
- Formal mentorship program, robust biweekly internal networking events and multiple communication streams open to senior management for all employees to provide continuous feedback.
- Employeefriendly work environment, with opportunity to participate in employeeled clubs (for example, book club, French club, gardening club,
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