System Architect - Medical Devices

System Architect - Medical Devices

Onera Health

Eindhoven, Netherlands

Job Description

We are seeking a highly skilled and experienced System Architect to lead the design and development of innovative medical devices. The ideal candidate will possess deep knowledge of medical device systems, regulatory requirements, software and (electronics) hardware and a proven track record in optimizing cost per component without compromising quality and compliance.

Key Responsibilities

System Design and Architecture:

• Lead the architecture design of medical device systems, ensuring they meet functional, safety, and regulatory requirements;
• The ability to apply a holistic approach ("System of Systems"), as our solution encompasses algorithms and platform next to the device itself;
• Develop detailed system specifications and design documents;
• Ensure the architecture is scalable, maintainable, and adaptable to future requirements;
• Ensure design for manufacturability and cost optimization. Work with manufacturing and procurement to source cost-effective components without compromising on quality and compliance.

Technical Leadership:

• Provide technical guidance and mentorship to engineering team. Act as the technical face of the team;
• Collaborate with cross-functional teams including R&D, QA, regulatory affairs, and manufacturing;
• Stay updated with the latest technological advancements and integrate relevant innovations into the product design.

Regulatory Compliance:

• Ensure all designs comply with relevant medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601);
• Prepare and review documentation required for regulatory submissions;
• Participate in regulatory audits and assessments as needed.

Management:

• Together with project and product managers develop & own project plans, timelines, and budgets;
• Act in total context (business, markets, customer roadmaps, overall ecosystem), driving for convergence.

Requirements

Education:

• Bachelor’s or Master’s degree in Electrical, Electronics, Software or Biomedical Engineering, or a related field.

Experience:

• Minimum of 8 years of experience in system architecture and design preferably within the medical device industry;
• Strong expertise in software and electronics, specifically;
• Proven experience in cost optimization for medical device components and systems;
• Knowledge of medical device regulations and standards (e.g., FDA, ISO 13485, IEC 60601) is a plus.

Skills:

• Strong analytical and problem-solving skills;
• You combine analytical and architectural thinking, physical insight, flexibility and a hands-on mentality;
• Excellent project management and organizational abilities;
• Effective communication and interpersonal skills.