Huidige banen gerelateerd aan System Architect Medical Devices - Eindhoven, Noord-Brabant - The Next Chapter W&S
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System Architect Medical Devices
3 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 costeffective 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 crossfunctional 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
- 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 is preferred.
Skills:
- Strong analytical and problemsolving skills.
- You combine analytical and architectural thinking, physical insight, flexibility and a handson mentality.
- Excellent project management and organizational abilities.
- Effective communication and interpersonal skills.
Benefits:
What We Offer
- Opportunity to work on cuttingedge 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
