Senior Product Engineer

3 weeks ago

West Northumberland County Millbrook, 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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