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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