Medical Device Systems Architect
4 weken geleden
Job Title: Medical Device Systems Architect
We are seeking a highly skilled and experienced Medical Device Systems Architect to lead the design and development of innovative medical devices at Onera Health. 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.
Key Responsibilities:
- 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.
Requirements:
- Bachelor's or Master's degree in Electrical Engineering, Biomedical Engineering, or a related field.
- 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.
Benefits:
- 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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