Design Assurance Manager

**Design Assurance Manager**:

- Remote Eligible: Hybrid- 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 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
- 8+ 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 on-site and remote work, paired with flexible working hours.
- A strong commitment to mental health and well-being, including a company-paid meditation app, meditation rooms in some buildings, fully trained Mental Health First Aid staff members, and weekly yoga/HIIT/Pilates/mindfulness online professionally-led classes for all employees.
- Headquarters based roles offer functional outdoor spaces (bring your laptop to one of multiple wi-fi connected outdoor patios to work) and access to a beautiful ravine trail system for lunchtime walks.
- Employer subsidized gourmet, high-quality, 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; employer-hosted 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.
- Employee-friendly work environment, with opportunity to participate in employee-led clubs (for example, book club, French club, gardening club,