Senior Design Assurance Engineer
Senior Design Assurance Engineer
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Job Description
Additional Locations:Canada-ON-Mississauga; Canada-ON-Toronto
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific well give you the opportunity to harness all thats 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 well help you in advancing your skills and career. Here youll be supported in progressing whatever your ambitions.
Our team is growing and we are currently looking for a Senior Design Assurance Engineer to join our Design Assurance Quality team. This position works closely with Medical Ultrasound Imaging products to ensure adequate design controls. The Design Assurance Engineer will serve as a Quality representative to improve awareness visibility and communication on quality initiatives to support assigned departmental functional site divisional and corporate quality goals and will provide design support.
Your responsibilities will include:
- Work within a cross-functional team to identify and implement effective controls and support product development through commercialization.
- Responsible for design control risk management & Usability of next-generation capital equipment Ultrasound Imaging devices.
- Uses clinical knowledge to influence how devices they are working on are tested and designed
- Applies sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues
- Independently or as a member of a team develops directs and executes plans for design control and risk management of complex projects
- Leads the implementation and development of product risk management tools (i.e. Hazard Analysis Fault Tree FMEAs)
- Adds to and promotes the culture of quality-centric patient care and customer satisfaction within the New Product Development team
- Promotes and influences compliance to BSCs quality business systems & Industry regulations
- Provides quality input (SME and/or independent reviewer) as required at defined project/product/process milestones (e.g. design reviews project design plans design/process changes to existing product lines).
- Other duties as required.
Required qualifications:
- Bachelors Degree in Engineering (Electrical Engineering Systems Engineering Biomedical)
- 5 years of relevant work experience
- Knowledge of Ultrasound imaging devices & IEC
- Knowledge of ISO 13485 ISO 14971 IEC 62366-1
- Experience with design controls design inputs and outputs and risk mitigation activities
- Experience with systems and electrical/software design and test experience with IEC 60601-1 and collateral standards
- Excellent analytical and communication skills (written and oral)
- Excellent organization and time management skills
- Interest in biomedical or health-related industry
Preferred qualifications:
- 2 years of experience in a Design Assurance role
- 5 years of experience in the medical device industry
Requisition ID:612736
Minimum Salary: $79700
Maximum Salary: $158200
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) see --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 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 salaried non-sales roles may also include variable compensation i.e. annual bonus target and long-term incentives (subject to plan eligibility and other requirements).
Compensation for sales roles is governed by Sales Incentive Compensation Plan (which includes certain annual non-discretionary incentives based on predetermined objectives).
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) isnt just business its personal. And if youre 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!
Required Experience:
Senior IC
Employment Type
Full Time
