System Architect Medical Devices
5 maanden geleden
**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**:
**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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