System Architect - Medical Devices

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. This position is offered as a 1-year contract.

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. 
• 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. 

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. 

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