Mechanical Engineer

 

We are looking for a motivated Mechanical Engineer to join our dynamic start-up. Please send your CV and cover letter to Brianna Carrels at bcarrels@guidestarmd.com

 

About the company:

GuideStar Medical Devices is a med-tech start-up based in Victoria, British Columbia. Our team is committed to delivering world-class solutions to real medical problems, transforming the way doctors use technology. Our goal is to design and manufacture ingenious medical devices that transform medical procedures, improve safety, and reduce cost, with solutions that could be accessible to practitioners around the world. We are seeking a highly motivated Engineer with experience in medical device design and design for manufacturing. An ideal candidate will have experience in a regulated industry, such as medical device development and/or manufacturing. We are a small team so we are looking for an exceptional person who works well with others in a collaborative environment.

 

Responsibilities:

  • Serve as technical lead. Provide technical leadership to engineering team. Wear many diverse technical hats.

  • Develop and test new manufacturing processes.

  • Update 3D modeling and drawings of medical device. Modify (as needed) technical device design.

  • Set specifications for manufacturing, design freeze.

  • Ongoing management of manufacturing contractors to build components to specification.

  • Clearly document design procedures and ensure regulatory compliance through design controls and risk management.

  • Estimate time and resources required for product development, monitor progress and provide regular updates to the team.

  • Designing, building, and testing of jigs for assembly.

  • Create product requirements, design specifications and device descriptions, as required by applicable medical device standards and internal procedures.

  • Create protocols and perform product verification and validation testing.

  • Technical assistance for verification testing.

  • CAPA management.

  • Writing of manufacturing sections for FDA and other regulatory submissions.

  • Planning of specifications for ongoing verification testing of manufacturing.

  • Troubleshooting manufacturing issues.

 

Required Skills and Experience:

  • 3+ years in working in Medical Device industry.

  • Experience with and understanding of design for manufacturing (injection molding).

  • Experience with managing external vendors.

  • Familiarity with ISO 13485 and associated protocols, or similar regulatory environment.

  • Experience and strong capabilities with Solidworks.

  • Self-motivated and self-directed.

  • Experience in analyzing and solving problems and providing recommendations for resolution.

 

Education:

Bachelor’s degree in Mechanical Engineering or equivalent experience

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Our Address
201-2067 Cadboro Bay Road

Victoria, BC, Canada

V8R 5G4

Office: 250-940-0015