System Architect

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