Description
Position Overview
We are seeking a Principal Systems Engineer with expertise in electrical engineering and working knowledge of biosensing or related principles. This senior-level role is responsible for the integration of complex electromechanical subsystems and sensors into advanced medical devices. The Principal Systems Engineer will drive systems architecture decisions, ensure technical alignment across multiple disciplines, and provide technical leadership to internal teams and external partners.
Key Responsibilities
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Serve as the technical lead for integrating electrical, biochemical, software, and fluidic subsystems.
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Guide architecture and design trade-offs to balance performance, safety, and compliance.
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Collaborate with external development partners and internal R&D, clinical, and regulatory teams.
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Translate user and clinical requirements into system-level specifications.
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Lead design reviews, risk assessments, and technical planning across cross-functional teams.
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Oversee verification and validation testing for sensors and system compatibility.
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Ensure adherence to regulatory standards including ISO 13485, IEC 60601, and FDA guidance.
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Mentor junior engineers and provide systems-level problem-solving expertise.
Minimum Qualifications
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Bachelor’s degree in Electrical Engineering or related field.
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7+ years of progressive experience in medical device or diagnostics development.
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Proven record of systems integration and risk management in regulated industries.
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Strong communication and leadership skills in cross-functional settings.
Preferred Qualifications
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Master’s degree in Electrical, Biomedical, or Computer Engineering.
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Experience with biosensor applications and monitoring technologies.
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Familiarity with design control, product lifecycle processes, and device integration.
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Knowledge of signal processing, fluidics, or biocompatibility.
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Prior experience managing external development teams or OEM suppliers.