Design Assurance Team Leader
5 months ago
**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.
- 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- **Job Segment**:Biomedical Engineering, Medical Device, Manager, Compliance, Document Control, Engineering, Healthcare, Management, Legal, Administrative
-
Design Assurance Engineer Leader
2 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeBoston Scientific is a global leader in the medical device industry, and we are committed to advancing science for life. Our mission is to solve the challenges that matter most by creating innovative medical solutions that improve patient lives.As a Senior Design Assurance Engineer at Boston Scientific, you will play a critical role in ensuring the quality...
-
Quality Assurance
5 months ago
Mississauga, Canada Baylis Medical Technologies Inc. Full time**The Big Picture** The Quality Excellence & Assurance Team Leader plays a crucial role in leading the quality team to uphold and enhance quality standards in alignment with regulatory and company requirements. This role combines hands-on leadership with strategic project management, requiring mature quality assurance knowledge for planning, conducting, and...
-
Quality Assurance Manager
6 months ago
Mississauga, Canada RMF Design and Manufacturing Inc. Full time**Job Description for a Quality Assurance Manager** This position is an ideal opportunity for a Quality professional who is looking for a job with a great deal of variety, enjoys coaching people, making decisions and being a team leader. **The Company** We are a Canadian contract electronic design and manufacturing company. Our quality system is certified...
-
Design Assurance Engineer I
4 months ago
Mississauga, Canada Boston Scientific Full timeAbout the role: Our team is growing, and we are currently looking for a Design Assurance Engineer I to join our Quality team. This position works closely with New Product Development teams to ensure risk management is applied and to ensure adequacy design controls as well as production and process controls. Our team also works to enhance quality as a...
-
Design Assurance Quality Specialist
2 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout Boston ScientificWe are a global leader in medical science, dedicated to solving challenges that matter most. Our mission is to advance science for life, transforming lives through innovative medical solutions that improve patient outcomes and create value for our customers.Estimated Salary: $85,000 - $110,000 per yearOur salary estimates are based on...
-
Senior Design Assurance Manager
4 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleBoston Scientific is seeking a highly skilled Senior Design Assurance Manager to lead our Access Solutions franchise in Mississauga, ON. As a key member of our Electrophysiology division, you will be responsible for developing and sustaining single-use devices for improving workflow to gain access to the left side of the heart.This exciting...
-
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking a Senior Design Assurance Engineer to join our Design Assurance Quality team at Boston Scientific.Key Responsibilities:Lead design control and risk management of novel electrophysiology devices, ensuring adequate design controls are met and subsequent production and process controls are adequate.Collaborate with new product...
-
Principal Design Assurance Expert
2 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking an exceptional Senior Design Assurance Engineer to join our dynamic team at Boston Scientific. This is a unique opportunity to leverage your expertise in design control and risk management of novel electrophysiology devices, influencing how devices are tested and designed through clinical knowledge.Key ResponsibilitiesLead design...
-
Medical Device Design Assurance Expert
3 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleWe are seeking an experienced Medical Device Design Assurance Expert to join our Quality team. In this role, you will work closely with New Product Development teams to ensure that risk management is applied effectively and design controls are adequate.Your Responsibilities Will Include:Working within a team to identify and implement effective...
-
Senior Design Assurance Manager
4 weeks ago
Mississauga, Canada Boston Scientific Full timeAdditional Locations: Canada-ON-Mississauga; Canada-ON-TorontoDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...
-
Senior Design Assurance Engineer
4 months ago
Mississauga, Canada Boston Scientific Full timeAdditional 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...
-
Lead Design Assurance Specialist
2 weeks ago
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the OpportunityBoston Scientific is a global leader in medical science, committed to solving challenges that matter most. We're united by a deep caring for human life and are dedicated to advancing science for life. Our mission is to create innovative medical solutions that improve patient lives, create value for our customers, and support our...
-
Senior Design Assurance Engineer
3 weeks ago
Mississauga, Canada Boston Scientific Full timeAdditional Locations: Canada-ON-Mississauga; Canada-ON-TorontoDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...
-
Mississauga, Ontario, Canada Boston Scientific Full timeAbout the RoleBoston Scientific is a leader in medical science, committed to solving challenges that matter most. We are seeking a Senior Design Assurance Engineer for Medical Devices to join our Quality team.Job DescriptionThe successful candidate will work closely with New Product Development teams to ensure risk management and design controls. They will...
-
Production Team Leader
2 months ago
Mississauga, Canada DBG Canada Full timeReporting to the Manager, A team leader will be assigned to overview a specific area or function within the operation. The incumbent will perform duties and have senior knowledge within at least one job classification. Team leader will report to Production Manager. The team leader will not be responsible for supervisory duties such as discipline but may...
-
Mississauga, Ontario, Canada Hatch Full timeJob DescriptionWe are seeking an experienced Electrical Design Leader to join our team in Mississauga, ON, Canada. As a Senior Electrical Designer, you will be responsible for supervising a team of electrical designers and assisting in the development and production of deliverables required for Mining, Energy and Infrastructure projects from Feasibility...
-
Design Assurance Engineer III
4 months ago
Mississauga, Canada Boston Scientific Full timeAdditional 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...
-
Sales Team Leader
3 weeks ago
Mississauga, Ontario, Canada SOFA BY STYLISH DESIGN INC. Full timeAt SOFA BY STYLISH DESIGN INC., we seek an experienced Senior Sales Manager to lead our sales team.Key responsibilities include:Assign sales workers to duties and oversee the performance of sales staffHire and train sales representatives, and arrange for their trainingAuthorize payments and handle merchandise ordersEstablish work schedules and ensure the...
-
Mechanical Designer
2 weeks ago
Mississauga, Canada TDG Transit Design Group Inc Full timeMechanical Designer/ Technologist (6 month contract)Location: Mississauga, ONHours: Monday- Friday 9:00 am-5:00 pmWho we are:TDG is a global leader in building complete interior and exterior lighting systems for rail applications. Our Company has been presenting innovative lighting solutions to the rail and public transportation industries since 1989. With...
-
Mechanical Designer
2 weeks ago
Mississauga, Canada TDG Transit Design Group Inc Full timeMechanical Designer/ Technologist (6 month contract)Location: Mississauga, ONHours: Monday- Friday 9:00 am-5:00 pmWho we are:TDG is a global leader in building complete interior and exterior lighting systems for rail applications. Our Company has been presenting innovative lighting solutions to the rail and public transportation industries since 1989. With...
