System Architect

4 maanden geleden

Eindhoven, Nederland Onera Health Voltijd

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. 

Onera
Onera Health is a leader in transforming sleep medicine and remote monitoring. Our breakthrough diagnostic solutions and services are poised to help millions of people struggling with sleep-related ailments, while also impacting other medical fields by monitoring a variety of chronic conditions, ultimately improving the health and quality of life for patients around the world. The company's innovative solutions provide comprehensive sleep test data to physicians in a variety of clinical and non-clinical environments to optimize patient care and reduce healthcare costs.

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. 

Benefits

What We Offer 

  • Opportunity to work on cutting-edge medical device technology. 
  • Collaborative and innovative work environment. 
  • Competitive salary and benefits package. 
  • Professional growth and development opportunities. 
  • Technical equipment to set up a home office

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