Only 24h Left: Design Assurance Engineer II
2 weeks ago
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 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
Our team is growing, and we are currently looking for a Design Assurance Engineer II to join our Design Assurance team. This position works closely with New Product Development and Product Life Cycle teams to ensure risk management is applied, adequate design controls are met, and subsequent production and process controls are adequate.
Your responsibilities will include:
- Managing and updating product risk management files, specifically Risk Management Plans, Reports, Hazard Analysis, Task Analysis, Design FMEAs.
- Collaborating within a team to identify and implement effective controls to support development or maintenance of products to meet internal and external requirements.
- Using clinical knowledge/data to influence how devices you are working on are tested and designed.
- Applying technical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Identifying and driving continuous improvement projects and quality initiatives by partnering and communicating effectively with various functions.
- Building quality into all aspects of work by maintaining compliance to all quality requirements.
- Planning, organizing, and prioritizing own daily work routine to meet established schedule.
- Utilizing standard statistical analysis and problem-solving techniques to determine product acceptance and evaluate process capabilities.
- In all actions, demonstrating a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Other duties as required.
Required qualifications:
- Bachelor's Degree in Biomedical Engineering, Mechanical or Electrical Engineering
- 2+ years of related work experience from the medical device industry
- Knowledge of ISO 13485, ISO 14971
- Demonstrated interpersonal skills with the ability to work within a team environment
- Must be able to work independently under limited supervision
Preferred qualifications:
- Six Sigma problem-solving methodologies
- Training experience to FDA regulations or ISO standards
Requisition ID: 601944
Minimum Salary: $57,200
Maximum Salary: $113,700
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) 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.
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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