Senior Product Engineer

2 weeks ago

Concord, Canada SpinaFX Full time

Senior Product Engineer - SpinaFX

 

Are you passionate about engineering innovations that save lives? Do you thrive in a dynamic environment where you can apply your expertise in product electrical engineering? Join us at SpinaFX Medical, a medical treatment solution company providing rapid and sustained relief to patients with back pain due to contained lumbar herniated discs, where you can make a real impact on healthcare worldwide.

 

We are seeking a talented Senior Product Engineer with extensive electrical engineering experience in the medical device industry to join our team. As a key member of our engineering department, you will play a critical role in the development, maintenance, and enhancement of our cutting-edge medical devices.

 

Key Responsibilities: 


-      Work closely with an interdisciplinary team in the design, development, and implementation of new medical devices from concept to commercialization.

-      Utilize your expertise in electrical engineering to ensure the successful integration of various components in medical device systems.

-      Manage and maintain Device History File (DHF) and Device Master Record (DMR) in compliance with regulatory requirements.

-      Plan, create and execute design verification and validation test protocols in adherence to quality standards and regulatory guidelines.

-      Collaborate with contract manufacturers to optimize manufacturing processes and ensure product quality and scalability.

-      Drive continuous improvement initiatives to enhance product performance, reliability, and cost-effectiveness.

-      Investigate product failures, non-conformances, and complaints, as needed. 

 

Qualifications: 

-      Bachelor's degree in electrical, systems engineering or equivalent engineering discipline; advanced degree preferred.

-      Minimum of 10 years of experience in the medical device or a regulated industry, with a proven track record of successful product electrical engineering.

-      Proficiency in managing DHF, DMR, and other regulatory documentation in compliance with FDA and ISO standards preferred.

-      Strong knowledge of engineering principles and practices, including design controls, risk management, and verification/validation processes preferred.

-      Experience working with contract manufacturers and outsourcing partners to bring products to market.

-      Excellent communication, leadership, and problem-solving skills.

-      CAD experience with Solidworks is a plus.

-      Project Management certification (e.g., PMP) is a plus.

 

Workplace type:


In office

 

Job location:


Toronto, Ontario, Canada 

 

Job type:


Full-time

 

 

To apply, please submit your resume to:


careers@spinafx.com

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