Senior System Engineer – Medical Devices

Responsibilities:

• Technical Leadership: Provide technical leadership and oversight for diverse, distributed teams of engineers in the development of complex medical devices, including hardware, mechanics, algorithms, and software, from concept to release.
• Requirements Management: Translate customer needs into actionable system technical requirements, support platform architecture decisions, and develop associated project execution plans.
• Communication: Translate technical findings into clear and concise recommendations for senior stakeholders.
• Multidisciplinary Collaboration: Collaborate across cross-functional teams to create, verify, manage, and track system and subsystem-level requirements and specifications.
• Development Methodology Expertise: Demonstrate leadership and advanced knowledge of software, hardware, and electronics development methodologies (Waterfall, Agile, etc.).
• Project Management: Plan and oversee task breakdown and execution within design teams, ensuring project development is delivered on time and to quality standards.
• Risk Management: Work with development teams to support risk analysis, design FMEA (Failure Mode and Effects Analysis), and identify appropriate risk mitigation solutions for complex robotic surgical systems and subsystems.
• Integration and Testing: Provide technical leadership in system integration, testing, verification, problem-solving, and product improvements.
• Regulatory Compliance: Oversee and maintain deep understanding of development processes regulated by relevant standards (e.g., risk management, usability). Ensure system design and documentation comply with these standards.
• Hands-on Development: Participate in hands-on work on system hardware components and software when developing new capabilities and features.
• Clinical Knowledge: Attend R&D labs and surgical observations to gain in-depth clinical understanding.
• Stakeholder Collaboration: Work closely with relevant stakeholders (PMO, Product, Clinical, Service, QA, DA, etc.).
• Development Lifecycle Support: Support key processes in the development life cycle, such as: sustainability investigations, software and hardware optimization, technical experiments, risk management, usability validation, and UI/UX specifications.

Qualifications:

Must Haves:

• Bachelor’s or Master’s degree in Biomedical Engineering, Electrical Engineering, Software Engineering, Robotics, Algorithms, or System Engineering from a recognized institution.
• Experience in the full product development lifecycle of complex medical device systems or other regulated fields, from initial concept to market release.
• Demonstrated technical leadership and ownership of projects.
• Proven ability for analytical problem solving, troubleshooting, and issue investigation.
• Ability to provide guidance and direction to less experienced technical personnel.
• Track record of strong cross-functional collaboration, influencing, and management skills to lead highly effective project teams.
• Self-driven, “can-do” attitude with initiative.
• 2+ years of experience as a System Engineer in medical devices or other highly regulated industries.
• 3+ years of hands-on technical and development experience in electrical engineering, software engineering, biomedical engineering, or robotics.
• Excellent teamwork skills with a talent for building team engagement.
• Fluency in technical English (written and verbal).
• Ability to travel up to 20% of the time.
• Valid driver’s license.

Advantages:

• Experience in system engineering of complex medical devices (highly preferred).
• Experience in electro-surgery (highly preferred).
• Expertise in software, hardware, electronics, and algorithm characterization and requirements writing (highly preferred).
• Development experience in a regulated environment (advantage).
• Skills in system performance modeling, simulation, and testing using tools like Python or Matlab (advantage).
• Global company experience (advantage).
• Image processing background (advantage).