Hybrid System Architect – Medical Devices

at Onera Health

• Job title: System Architect – Medical Devices
• Job type: Contract
• Experience level: Senior, Lead
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Eindhoven, Netherlands

About the role

• System Architect responsible for medical device system design and architecture at Onera Health. Leading technical teams to optimize solutions for sleep medicine and remote patient monitoring.

Responsibilities

• **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

• **Qualifications: **
• **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.

Benefits

• **What We Offer **
• Opportunity to work on cutting-edge medical device technology.
• Collaborative and innovative work environment.
• Competitive salary and benefits package.
• Technical equipment to set up a home office