Job Title: Senior Systems Engineer
As a seasoned professional in systems engineering, you will play a pivotal role in the development of cutting-edge medical technologies by integrating hardware, software, and fluidics in regulated clinical environments.
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Key Responsibilities:
* Lead complex systems engineering activities for electro-mechanical medical device platforms.
* Translate user needs and clinical requirements into system-level specifications.
* Define and manage requirements traceability, risk analysis, and design inputs/outputs.
* Collaborate with cross-functional teams to ensure integrated product development.
* Support design verification and validation, including test planning and execution.
* Ensure compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
* Participate in design reviews, FMEA, and hazard analysis.
* Provide technical leadership and mentorship to junior engineers.
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Ideal Candidate Profile:
* Proven experience in medical device systems engineering, preferably with electro-mechanical or drug delivery systems.
* Strong understanding of embedded software, fluidics, and hardware integration.
* Familiarity with design controls, risk management, and regulatory compliance.
* Excellent communication and documentation skills.
* Ability to work independently and collaboratively in a fast-paced, regulated environment.
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Preferred Qualifications:
* Bachelor's or Master's degree in Systems Engineering, Biomedical Engineering, Electrical/Mechanical Engineering, or related field.
* 5+ years of experience in medical device product development.
* Experience with tools such as DOORS, Jama, or equivalent for requirements management.
* Knowledge of IEC 62304 and human factors engineering is a plus.
This role demands strong technical expertise, excellent communication skills, and the ability to work collaboratively in a fast-paced environment. If you have experience in medical device systems engineering and are looking for a challenging role, please apply.