Company: | NATUS |
---|---|
Job Role: | Senior Systems Engineering. |
Experience: | Freshers. |
Vacancy: | 35+ |
Qualification: | Bachelors Degree in Engineering or related skills. |
Salary: | C$ 120,900/year. |
Location: | Ontario - Oakville - Canada. |
Join us on Telegram | Click Here |
Apply Mode: | (Online) |
Deadline: | Not Mentioned |
- You enjoy impacting all phases of a product life cycle
- You thrive on developing clear and robust requirements that the development, verification, and validation teams will follow
- You like having the big picture visability into product lifecycle cost including development, launch, maintenance, and warranty
- You are a long-term thinker and pro-actively set the stage to allow for future updates
- Competitive salaries
- Comprehensive benefit package that starts your first day
- Paid Holidays
- Paid time off plan (3 weeks, 7 sick days)
- Tuition reimbursement up to $5,000 annually, Udemy Online Learning
- Location: This role can be based out of our Natus Oakville, ON or Ottawa, ON site with hybrid flexibility or 100% Remote in North America
- Drive design history file remediation programs and complete and review all systems engineering deliverables.
- Ensure engineering quality of the Design History File (DHF)
- Address containment actions, identify root causes, and implement corresponding actions as part of the CAPA process.
- Establish traceability between design inputs, design outputs, and verification and validation
- Coordinate with software developers, hardware engineers and mechanical engineers to ensure optimal performance of the system
- Integrate custom-design medical devices and software with third-party components into fully functional systems
- Contribute to risk management related activities and usability testing
- Participate in quality improvement, complaints investigation, change control, and safety assessment processes
- Contribute to harmonizing the company’s various medical device platforms by converging system architecture and reusing components as well as design and test practices (product line engineering)
- May work in a lead designer role or lead projects involving cross-functional teams on new product development programs
- Travel: up to 25% domestic or international travel on a project need basis.
- Bachelor’s degree in Engineering or Science and minimum three years’ relevant systems engineering experience in the medical device industry
- Experience with medical device technology, applicable quality and safety standards, and regulations
- Experience with requirements specification and traceability. You know how to write product requirements from user requirements and take it through verification and validation
- Demonstrated ability to deal with a fast-paced environment, high levels of ambiguity, multiple concurrent projects, and conflicting assignments
- Demonstrated initiative, attention to detail, customer focus, and commitment to ongoing process improvement
- Bachelor’s degree in Engineering or Science; Master’s degree is an asset, and minimum five years’ relevant systems engineering experience in the medical device industry. A combination of education and experience may be considered.
- Extensive experience with medical device technology, applicable quality and safety standards, and regulations
- Clear communication skills to effectively interact with all levels of the business
- Global project leadership experience
- Extensive experience with requirements specification and traceability. You know how to write product requirements from user requirements and take it through verification and validation with a future-thinking mindset
- Experience with CAPAs and DHF remediation for legacy products
- All other requirements are the same
How to Apply Click on the Below link, it will redirect you to source Page and apply there.
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