Systems Engineer - Medical Device

Fusion Life Sciences Technologies is seeking a highly skilled and experienced System Engineer to join their team. The ideal candidate will have 5-8 years of experience in the medical device industry, with a strong focus on Design Controls, traceability, and design validation. The Systems Engineer will lead efforts to develop and implement robust design control processes for new and existing products, ensuring compliance with FDA regulations (21 CFR 820), ISO 13485, and other relevant industry standards.

Requirements

• 5-8 years of experience in system engineering within a regulated environment, preferably in medical devices or other highly regulated industries.
• Strong experience in implementing and managing design controls processes, including traceability, user needs, and design verification/validation.
• Proven ability to ensure full traceability from user needs to design validation and manage product documentation accordingly.
• In-depth knowledge of FDA regulations (21 CFR 820), ISO 13485, and other applicable standards for medical devices.
• Strong communication and interpersonal skills, with experience working effectively in cross-functional teams.
• Strong verbal and written communication in English