Senior Product Engineer, Applications

2 weeks ago

Concord ON, 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.
 
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. 
 
Bachelor's degree in electrical, systems engineering or equivalent engineering discipline; 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.
- CAD experience with Solidworks is a plus.
- Project Management certification (e.g., In office
 
Full-time
 
 

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