Senior System Engineer – Role Overview
Are you a senior engineer who thrives at the intersection of mechanics, electronics and software? Do you enjoy owning complex systems end-to-end and providing technical leadership in highly regulated environments? Then this role could be your next step. As Senior System Engineer you act as the technical lead and system owner for advanced upper‑limb bionic products, ensuring overall technical integrity of the system by aligning mechanical, electrical and software teams toward a common, well‑defined vision. You take ownership of the system throughout the entire development lifecycle – from early concept development and requirements definition through detailed design, verification, validation and delivery – translating user needs and stakeholder input into clear, traceable system and technical requirements while continuously balancing performance, safety, reliability, risk and feasibility.
Key Responsibilities
* Lead the technical direction of complex medical device systems.
* Define, document and manage system and product requirements, ensuring full traceability.
* Translate high‑level needs into detailed technical requirements and system architecture.
* Optimize overall system design for performance, safety, reliability and maintainability.
* Drive cross‑functional alignment across mechanical, electrical and software teams.
* Lead risk management activities (FMEA, Fault Tree Analysis, Hazard Analysis).
* Own the Design History File (DHF) / Technical File and change control process.
* Guide verification, validation and clinical testing strategies.
* Ensure compliance with medical device standards and regulations (MDR, ISO 13485, ISO 14971, IEC 60601‑1).
Qualifications & Experience
* Engineering degree (Systems, Mechanical, Electrical, Software or Biomedical); advanced degree preferred.
* Experience in regulated industries, ideally medical devices.
* Strong expertise in one engineering discipline with solid understanding of the others.
* Proven experience as a Systems Engineer or Technical Lead.
* Ability to work autonomously and make balanced technical decisions.
* Strong communication skills, able to translate complex topics for diverse audiences.
Benefits
You’ll work on life‑changing bionic technologies, with real ownership, high autonomy and direct impact. This is a senior, influential role where your technical judgment truly shapes the product and the lives of the people who use it.
EEO Statement
Embla Medical is an equal opportunity employer and makes employment decisions on the basis of merit. We want to have the best available individual in every job. Embla Medical's equal opportunity policy prohibits all discrimination (based on race, color, creed, sex, religion, marital status, age, national origin or ancestry, physical disability, mental disability, military service, pregnancy, child birth or related medical condition, actual or perceived sexual orientation, or any other consideration made unlawful by local laws around the world). Embla Medical is committed to complying with all applicable laws providing equal employment opportunities. This commitment applies to all individuals involved in the operations of Embla Medical and prohibits discrimination by any employee of Embla Medical, including supervisors and co‑workers.
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