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Senior Design Engineer – Medical DevicesIntellectt INC • Woodbridge, ON, Canada
Senior Design Engineer – Medical Devices
Intellectt INC • Woodbridge, ON, Canada
19 hours ago
Job type
- Full-time
- Quick Apply
Job description
Hello,
I hope you're doing well.
My name is Bhanu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a Senior Design Engineer Medical Devices based in Toronto, ON with one of our prestigious clients.
I would love to connect and discuss this opportunity in more detail. Please feel free to share your updated resume at bhanu@intellectt.com
Job Title: Senior Design Engineer Medical Devices
Location: Toronto, ON
Job Summary
We are seeking a Senior Design Engineer with a strong background in medical device product design and development. The ideal candidate will lead the design of innovative medical devices from concept through commercialization, ensuring compliance with regulatory standards while collaborating with cross-functional engineering and manufacturing teams.
Key Responsibilities
- Design and develop medical device components and assemblies from concept to production.
- Create and review 3D CAD models, detailed drawings, and engineering documentation.
- Perform design verification, validation, tolerance analysis, and risk assessments.
- Support prototype development, testing, design iterations, and product improvements.
- Collaborate with Manufacturing, Quality, Regulatory, and R&D teams throughout the product lifecycle.
- Participate in design reviews, DFMEA, root cause investigations, and design change activities.
- Ensure compliance with FDA, ISO 13485, IEC 60601, and applicable medical device regulations.
- Support manufacturing transfer, process development, and product launch activities.
Required Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- 5+ years of medical device product design and development experience.
- Strong proficiency with SolidWorks, Creo, or similar 3D CAD software.
- Experience with GD&T, DFMEA, Design Controls, Verification & Validation (V&V), and Design for Manufacturability (DFM).
- Knowledge of ISO 13485, FDA 21 CFR Part 820, ISO 14971, and medical device design control requirements.
- Experience working with cross-functional teams in a regulated medical device environment.
- Excellent analytical, problem-solving, and communication skills.
Preferred Qualifications
- Experience with Class II or Class III medical devices.
- Familiarity with injection molding, machining, plastics, and metal components.
- Experience supporting regulatory submissions and product commercialization.
Thanks & Regards,
Ajay Bhanu
Lead Recruiter
Intellectt Inc
Bhanu@intellectt.com
Direct: 732 784 4384
Desk number: 732 412 6999- Ext: 159
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Senior Design Engineer – Medical Devices • Woodbridge, ON, Canada
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