Principal R&D Systems Engineer
Baylis Medical
Toronto
2d ago

Overview

Our team is rapidly growing and we are currently seeking a Principal Research & Development Engineer, Systems to assist with the development of products.

This role will have a focus on Systems Engineering activities for a complex development project. Our engineers are involved in all aspects of the medical device development including : concept generation, design, prototyping, and manufacturing transfer.

These individuals also have an opportunity to work with the appropriate government bodies to obtain regulatory approval, and to issue patents in conjunction with the IP department.

At Baylis, we offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our team consists of intelligent and success-

driven individuals with a strong inspiration to improve the lives of others.

Snapshot of Responsibilities

  • Design and develop complex cutting-edge medical consoles or systems that include mechatronics, electronics and software through prototyping, testing and modeling.
  • Develop device design history files - Requirements, Risk Management, Usability Files
  • Ensure compliance to industry and international standards
  • Develop verification and validation plans, protocols, and reports
  • Support production activities
  • Support regulatory filings to various government bodies
  • Support the development of intellectual property
  • Support pre-clinical and clinical research activities
  • What you bring to the team :

  • Background in Systems, Mechanical, Electrical, or Biomedical Engineering degree required.
  • 8+ years working in the medical device industry with a focus on Research and Development
  • Experience working and coordinating external and internal teams on complex development projects
  • Experience with capital device development will be a huge asset.
  • Strong knowledge of the design requirements as per 21 CFR 820 and ISO 13485
  • Experience with drafting and maintaining DHF and DMR documentations
  • Ability to independently develops and adapts work plans based on vague or changing project goals
  • Strong hypothesis-driven experimental design and statistical analysis skills
  • Experience with mentoring junior engineers
  • Demonstrated experience in creative engineering design
  • Candidates should be self-starters and have a hands-on approach
  • Ability to work independently and within a diverse group of engineers and production staff
  • Superior communication skills (verbal / written) and demonstrate strong leadership skills
  • Possess a strong interest in biomedical technology
  • What we have to offer :

  • Smart commute options including complimentary shuttle from Kipling Station, and subsidized transit program.
  • Flexible working hours that complement core business hours.
  • One day off for volunteering, to give back to a charitable organization of your choice.
  • Purposeful work that drives career development, with opportunities to learn and grow by way of on-site training, workshops, and lunch and learn sessions.
  • Comprehensive total rewards package, including tuition reimbursement and lifestyle and health spending account.
  • Well-being initiatives, including onsite gym facility and fitness classes (yoga and boot camp).
  • Employee-friendly work environment, with opportunity to participate in employee-led clubs, organized sports teams, video games, foosball, ping pong, etc.
  • About Us

    At Baylis Medical, everyone works with a shared purpose : to improve the lives of people around the world. Named one of Canada’s Best Managed Companies, we are a rapidly growing leader in the development, manufacturing and commercialization of innovative medical devices in the field of cardiology.

    Our focus is on providing physicians clinically-relevant tools, so that no patient goes untreated.

    We are looking for talented individuals, like yourself, to join Baylis Medical and make an impact in the lives of patients.

    Are you ready to join us?

    Baylis Medical is an equal opportunity employer and encourages applications from all qualified individuals. Please inform us if you require any accommodations during the recruitment process

    While we thank all applicants, only those being considered for an interview will be contacted.

    Want an inside look at careers and life at Baylis? View employee profiles on The Muse and follow us on Instagram Baylismedical

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