11 дней назад
Principal Engineer, Systems (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Principal Engineer, Systems (Medical Devices): Developing and sustaining electromechanical dialysis devices by defining end-to-end system requirements with an accent on embedded software, hardware interfaces, safety, traceability, and medical-device compliance. Focus on decomposing user needs across mechanical, electrical, controls, and software domains, linking requirements to risk controls and verification, and resolving system integration and design conflicts.
Location: Whitefield, Bengaluru, Karnataka, India
Company
develops vital organ therapy products and digital solutions, building on a legacy in kidney care, dialysis, and acute therapies.
What you will do
- Lead the development, structuring, and decomposition of requirements for electromechanical medical-device projects.
- Translate system-level needs into functional, performance, interface, and safety requirements across mechanical, electrical, embedded, controls, and software domains.
- Establish bidirectional traceability between requirements, risks, architecture, design elements, and verification methods.
- Facilitate cross-functional reviews and support system architecture, integration builds, verification planning, and issue triage.
- Collaborate with clinical, marketing, human-factors, quality, regulatory, service, manufacturing, and global engineering stakeholders.
- Mentor junior engineers and support audits by presenting requirements, rationale, and traceability artifacts.
Requirements
- Bachelor’s or higher engineering degree in Electrical Engineering, Electronics, Computer Science, or a related discipline.
- 10–15 years of experience as a systems engineer or in a similar role.
- Proven experience developing electromechanical systems from concept through production, preferably in medical devices or other highly regulated products.
- Strong analytical, problem-solving, communication, and coordination skills.
- Experience addressing end-user or patient needs and independently handling production, field, or supply-chain issues.
- Knowledge of requirements management, configuration control, change management, and verification coverage analysis.
Nice to have
- Awareness of ISO and IEC medical-device design-control procedures, regulations, and standards.
- Working knowledge of dialysis equipment.
Culture & Benefits
- Meaningful work focused on extending patients’ lives and improving care-team efficiency.
- Collaboration across software, hardware, verification and validation, digital engineering, quality, regulatory, clinical, service, and manufacturing functions.
- Commitment to providing reasonable accommodations to individuals with disabilities during the application and interview process.
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