Senior Systems Engineering Manager
1 month ago
We are seeking a highly skilled and experienced Team Leader to join our Systems Engineering team. As a key member of our team, you will be responsible for leading a team of engineers in the development of complex biomedical systems to improve standard of care.
Key Responsibilities:- Lead a team of engineers in the development of complex biomedical systems.
- Act as the key central communications point for systems engineering related project activity.
- Conduct planning for broad, technical projects by applying mature engineering knowledge and soliciting input from other stakeholders where appropriate.
- Participate in short- and long-range planning at a program level.
- Provide technical and project-level leadership to engineering staff.
- Assign and outline work, advise on technical problems, review work for technical accuracy and adequacy.
- Track deliverables from internal and external teams against product design change requirements.
- Adhere to all requirements of the Quality Management System, maintaining the highest standards in our engineering processes.
Required Skills:
- Successful completion of a bachelor's Engineering degree (or equivalent) required with a focus on systems engineering, biomedical and/or electrical experience.
- Track record of design and development of biomedical systems, including interface design, algorithm development, and system testing.
- At least 5 years experience working in an engineering role.
- Experience with people leadership with experience supervising direct and/or indirect reports.
- Will be required to travel 25% of the time (typically a maximum of 5 to 7.5 days per month). Travel requirements include travel to the US and Canada. Valid passport is required.
- Ability to independently develop and adapt work plans based on vague or changing project goals.
- Strong hypothesis-driven experimental design and statistical analysis skills.
- Demonstrated experience in engineering design.
- Ability to work independently and within a diverse team of engineers, professional staff, and production staff.
- Superior communication skills (verbal/written) and demonstrated leadership skills.
- Organization and time management skills.
- Strong interest in biomedical technology.
- Dynamic, flexible approach to work with a results-oriented attitude.
Asset Skills:
- Experience in the medical device industry.
- Related experience in medical devices with a focus on Product Development & Research and Development.
- Knowledge of design requirements as per 21 CFR 820, IEC 60601-1, IEC 60601-1-2, and ISO 13485.
- Knowledge of risk management as per ISO 14971.
- Experience with drafting and maintaining DHF and DMR documentation.
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