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Mechanical System Engineer

Under the guidance and leadership of the Vice President of Research and Development (VP, R&D), you will work to design and fabricate bench scale prototypes that support ongoing product development. In this role, you will also liaise with research scientists to implement the infrastructure they need for their work and perform experiments. The Intermediate Engineer also assists Quality by maintaining laboratory equipment and supporting EHS/Quality initiatives.

Duties and Responsibilities:

  • Create 2D and 3D CAD models of prototype designs from hand drawings.
  • Plan, design, perform, and thoroughly document experiments.
  • Conceptualize, design, and fabricate laboratory equipment and prototypes.
  • Coordinate with the Operations, Quality, and Research Scientists to ensure that design criteria are met.
  • Author, execute and document verification and validation protocols and reports.
  • Source materials and tools required for prototyping.
  • Complete tasks accurately and in a timely manner without supervision.
  • Execute experimental plans developed in collaboration with the VP R&D, gather and analyze the data, and evaluate the efficacy of the plan. Once the efficacy is confirmed, transfer to Operations.
  • Initiate and own design changes to support design transfer, ensuring quality requirements are met.
  • Document research projects to ensure CryoStasis has clear and detailed history of collaborations and internal projects.
  • Support multiple projects in parallel, providing effective and flexible support to the organization.
  • Knowledge of medical device quality and regulatory standards an asset.
  • Work experience in a medical or pharmaceutical environment is an asset.

Education and Work Experience

Essential:

  • A bachelor's degree in mechanical engineering or in a related engineering discipline is required.
  • 3-5 years of hands-on practical experience building prototypes, with some experience in the medical device industry
  • Ability to design complex experiments and verification studies with attention to detail.
  • Ability to write protocols, technical reports, and other documents as needed.
  • Excellent familiarity with principles of Geometric Dimensioning and Tolerancing
  • Ability to properly, and safely, use 3D printers, laser cutters, lathes, CNC mills, hand and power tools, and other equipment commonly found in a machine shop.
  • Strong knowledge of manufacturing/fabrication techniques
  • Ability to prioritize and execute various tasks with minimal direction.
  • Demonstrates a sense of urgency, strong work ethic and a “can do” attitude.
  • Is curious, inquisitive, innovative, and strives to improve the status quo.
  • Willingness to take on challenges and view changes as opportunities.
  • Collaborates with others in a cross-functional environment.
  • Follows Quality System requirements, safety rules, and applicable regulations.

Asset:

  • A portfolio of sample work as part of your application
  • Understanding of biochemistry and/or medical device manufacturing
  • Basic coding experience (Python, Matlab, Excel VBA)
  • Thermodynamics background, specifically experience with refrigeration is a plus.

CryoStasis is an inclusive employer in every way, and we are committed to providing accommodation for people with disabilities. If you require accommodation, please notify the hiring manager and we will work with you to mutually address your needs.

Please send resume and cover letter (optional) to: careers@businesssherpagroup.com

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