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- 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 costeffectiveness.
- Investigate product failures, nonconformances, and complaints, as needed.
- 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
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Product Engineer - Concord, ON, Canada - SpinaFX
1 week ago
Description
Senior Product Engineer - SpinaFXAre 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.
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.
