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    Product development engineer - Toronto, ON, Canada - StarFish Medical

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    Description
    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 of the 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.

    The Senior Product Development Systems Engineer works with Program Management and the Technical team to identify the ideal technical solution for the client within Program constraints.

    You are 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.

    You will have varied assignments, some of which involve being the only Product Development Systems Engineer on the project, whereas on others, you may be directing the work of other team members.

    Given the variety in program constraints, you know there isn't a "one size fits all" solution, and the systems engineering approach will be tailored to the specific program 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.

    In this position, you will work alongside Program Managers, Project Managers and others on the Systems Engineering team.
    00 CAD. StarFish Medical works with external compensation consultants annually to ensure our ranges reflect the market and our compensation philosophy.

    StarFish Medical utilizes a career framework that outlines the skills, abilities, and behaviours required to move between different levels of a job family.

    Benefits of working at StarFish Medical

    Both locations offer shower facilities for midday runs or biking to work; Victoria offers Galloping Goose access close by, while Toronto offers a Bike Share station within a 5-minute walk to the Office.

    ~ Both locations offer free parking on-site or around the premises.

    Serve as a member of the Functional Management team, providing guidance, resourcing, and strategic approaches to software development for various novel medical devices.

    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 Product Development Systems Engineers and other supporting 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.

    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.
    Analyze "Modeling" vs "Build & Test" options to make strategic recommendations throughout the product development lifecycle.

    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.

    Support the development of regulatory strategy.
    Mechanical, Electrical or any Engineering related degree.
    Demonstrated ability to communicate technical concepts and requirements.
    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

    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.

    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. Please apply through the StarFish Medical Portal .

    If you experience difficulties with the StarFish Medical Job Portal, don't hesitate to contact with the subject line " Senior Product Development Systems Engineer | Job Portal Issue.

    "
    No phone calls, please.

    We also seek innovative and dedicated professionals from a wide range of backgrounds to complement our fulltime team on a contracting basis.

    Join over 6000 medical device professionals who receive our engineering, regulatory and commercialization insights and tips every month.
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