Description
About the Role
Our client is seeking a highly skilled Senior Electrical Engineer to join their R&D team. In this role, you will contribute to new product development while supporting the existing product portfolio. You will be responsible for electrical and electronics design, specification development, software and hardware integration, and ensuring compliance with global medical device standards. This position plays a key role in achieving revenue, quality, production, and cost-reduction goals.
Key Responsibilities
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Lead electrical engineering aspects of medical device design, including schematic capture, PCB layout, requirements management, verification test design, design transfer to manufacturing, and change management.
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Ensure product engineering aligns with global medical device design control requirements.
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Manage new product development projects involving electromechanical assemblies, electronics, wired/wireless communication design, and compliance with medical electrical safety and EMC standards.
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Collaborate cross-functionally with mechanical, software, quality, manufacturing, clinical, regulatory, marketing, and service teams to bring innovative products to market.
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Coordinate external lab testing to meet global standards such as IEC 60601-1 and related subparts.
Minimum Qualifications
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Strong verbal and written communication skills in English.
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Ability to work independently while contributing effectively to global product development teams.
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Hands-on technical aptitude with a solid grasp of engineering concepts including FEA, design for manufacturing, and design for quality.
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Proven ability to lead multiple projects and collaborate across multi-disciplinary teams.
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Experience with test method validation, verification, validation, analytical methods, and statistical design of experiments.
Preferred Qualifications
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Proficiency in ECAD software (Altium Designer preferred).
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Knowledge of medical device regulations and standards, including FDA QSR (21 CFR Part 820), EU 2017/745, ISO 13485, ISO 14971, and IEC 60601-1.
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Experience with injection molding.
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Proficiency in 3D CAD software (SolidWorks strongly preferred).