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Senior Systems Engineer

Senior Systems Engineer – Medical Device Development

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We seek a Senior Systems Engineer who embodies out-of-the-box systems thinking, relying on their deep knowledge of engineering concepts, medical domain, regulatory compliance, and user-centred design principles to facilitate the seamless development of complex medical devices that meet clients’ and patients’ needs. Given the varying constraints in medical device development, you know there isn’t a “one size fits all” solution, and the systems engineering approach will be tailored to the specific client’s needs. As an expert in System Engineering, you will contribute to developing processes, procedures and training material and may also deploy training to other staff members.

You will work with Program Managers and the Engineering team to identify the ideal technical solution for the Client within medical devices development constraints. You are also adept at building collaborative, cross-functional teams to be high functioning, and your communication skills successfully bring these diverse groups together to spawn creative, open-minded, and out-of-the-box thinking.

By joining StarFish Medical, you will make a difference in millions of lives worldwide. We are a product development and low-volume contract manufacturing consultancy focused on medical devices and laboratory test equipment. Many medical devices we consult on and manufacture are complex electromechanical systems, requiring our engineers and designers to work closely together to develop these systems.

Working at StarFish Medical ensures you will be part of an award-winning, multi-disciplinary development team that delivers elegant solutions, exceptional customer service, and final products that enable our customers’ commercial success. If you are looking for a workplace where you can make a difference and be recognized as a difference maker, then StarFish Medical is the place for you.

Location

Toronto, Ontario.

Benefits of working at StarFish Medical

An exciting career working with a genuinely talented and ambitious team, combined with:

  • The opportunity to work on ground-breaking technology.
  • Award-winning culture with deep-rooted Guiding Principles.
  • Profit-sharing program.
  • Excellent company-paid benefits package.
  • Paid vacation and sick leave, including a “vacation purchase program” to take more time off.
  • Monthly All-hands meetings.
  • Active social committee.
  • 50% TTC cost-sharing in Toronto.
  • The office has shower facilities for midday runs or biking to work. A bike Share station is within a 5-minute walk of the Office.
  • The location offers free parking on-site or around the premises.

Responsibilities

  • Develop and shape the technical solution(s) within program constraints for complex multi-disciplinary products at all development lifecycle phases.
  • Motivate, mentor and oversee an exceptionally talented and engaged team of Systems Engineers and other engineering staff on programs.
  • Accountable for the collection, definition and maintenance of requirements.
  • Lead architecture development, including system and sub-system decomposition activities, interface definition and interface management.
  • Formally drive techno-commercial decision-making processes (trade space analysis to ensure that decisions are made and documented efficiently, effectively and based on objective criteria.
  • Spearhead risk management activities (both program and patient/user).
  • Guide the technical team in prioritizing feature implementation to align with strategic client milestones/objectives.
  • Present options to Program Management for the technology development roadmap to bring the device from its current state to commercialization. This should include consideration of alternative life cycle methodologies.
  • Support the Program or Project Manager with appropriate system decomposition to enable detailed planning and estimating. Provide estimates, identify dependencies, and proactively highlight program risks as required.
  • Coordinate detailed design activities and system integration to ensure maintenance of interfaces and adherence to requirements.
  • Foster and maintain high-trust relationships with internal and external stakeholders to deliver on program vision.
  • Analyze “Modeling” vs “Build & Test” options to make strategic recommendations throughout the product development lifecycle.
  • Assess trade-offs for review by the PM to maintain alignment with both technological & client business goals (budget, schedule, competitive edge, etc.).
  • Accountable for design and development process adherence on programs, including compilation of the requisite documentation to support device DHFs.
  • Involved in defining the formal review of the design through various technical, design and phase-gate reviews.
  • Lead verification and validation planning and strategy.
  • Accountable for collection and assessment of verification and validation results.
  • Adhere to and enhance the Quality Management System (QMS), including developing and maintaining documentation and training other staff as appropriate.
  • Perform detailed design activities in area of expertise as required.
  • Support the development of regulatory strategy.

Qualifications, Skills & Attributes

  • Eng, B.A.Sc, or similar. Mechanical, Electrical or any Engineering related degree.
  • At least 10 years of relevant experience.
  • Demonstrated leadership capabilities.
  • Demonstrated systems thinking capabilities.
  • Strong communication skills (both verbal and written)
  • Ability to thrive in an environment of ambiguity and uncertainty.
  • Demonstrated ability to communicate technical concepts and requirements.
  • Demonstrated leadership and organizational skills.
  • Ability to rapidly understand new technologies and incorporate on-the-fly change of plans.
  • Meticulous attention to detail, including maintaining accurate records and traceability.
  • Experience writing, reviewing, and executing test plans.
  • Knowledge of medical device development in an ISO:13485 or other regulated industry is desired.

Thanks in advance for your interest in StarFish Medical!

Amazing Culture!

Our work environment received Canada’s Most Admired Corporate Culture awards for 2021, 2022 & 2023, recognizing best-in-class cultures that have helped enhance performance and sustain a competitive advantage. We are Canada’s leading medical device design service provider, providing a full complement of design, development, and low-contract manufacturing services in Victoria and Toronto. We successfully partner with innovative companies (both large and small) to create breakthrough products for several medical specialty areas.

Don’t meet every single requirement? Studies have shown that women and people of colour are less likely to apply for jobs unless they meet every qualification. At StarFish Medical, we are dedicated to building a diverse, inclusive, and authentic workplace. If you’re excited about this role but your experience doesn’t align perfectly with every qualification in the job description, we encourage you to apply anyway. You may be just the right candidate for this or other roles! Please apply through the StarFish Medical Portal.

If you experience difficulties with the StarFish Medical Job Portal, don’t hesitate to contact [email protected] with the subject line Senior Systems Engineer | Job Portal Issue.”

We thank all candidates who apply; however, only those selected for further consideration will be contacted after initial acknowledgement. No phone calls, please. 

We look forward to meeting you!

Senior Systems Engineer

Contractors

We also seek innovative and dedicated professionals from a wide range of backgrounds to complement our fulltime team on a contracting basis. To apply, please submit a cover letter outlining your interest, availability and rate to the email address listed above.

Co-op Students

Please see our Co-op Placements page for more information.

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