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, 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;
  • 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

Qualifications:

Education:

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

Experience:

  • Minimum of 8 years of experience in system architecture and design preferably within the medical device industry;
  • 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 preferred.

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.

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