System Architect Medical Devices
We usually respond within three days
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
Unfortunately, we can not offer work permit/visa sponsorship and therefore we can only consider your application if you have full working rights for The Netherlands.
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
- Business unit
- The Next Chapter W&S
- Locations
- Eindhoven
- Is work permit / visa sponsorship offered?
- No, only candidates with EU / EEA country nationality may apply.
- Is remote possible?
- No, this is an on-site role requiring to be based in The Netherlands., The company will offer hybrid working within a work week (part in-office, part from home).
- Is freelance possible?
- No, this is a permanent job with a regular contract of employment.
- Which language skills are required (professional level)?
- English
- Employment type
- Full-time, Regular - indefinite, Regular - temporary
We usually respond within three days
Eindhoven
About The Next Chapter W&S
We provide job opportunities in The Netherlands for IT and engineering professionals. We share relevant tips and tricks with jobseekers and we can support employers with regards to relocation, work permit rules, 30% ruling et cetera. We value transparancy, honesty and a no-nonsense approach based on our extensive technical and international recruitment expertise.