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Hardware Certification Specialist
2 weeks ago
Position : Hardware Certification Specialist
Application closes at : Feb 16th, 2025 23:00
With the X1 CBCT unit, we brought exciting and radical innovations to the field of dental radiology. To further develop and deploy the X1 CBCT unit globally, we are currently expanding our organization around the product. Towards that end, we need a skilled hardware certification specialist.
Spun out from the most successful Danish start-up company in recent years, we are a small team dedicated to bringing CBCT scanning to the next level by enabling true motion correction and high fidelity scanning to clinics across the world. To do this, we expect to grow our team substantially in the coming years. As we expand, we offer exciting opportunities for career development and influence in a growing team.
Innovation is in our DNA. We are energized by making a positive 'human' impact in the work we do. Teamwork is king, and we pride ourselves on providing an opportunity for the industry's best talent to spar, collaborate and learn from each other along the way. We do not know everything, but we are fast learners.
The Job
You will manage the certification process for our next generation scanning platform. This includes:
- Planning the certification process, including the identification of applicable standards from the 60601-1 and related families.
- Identifying and negotiating with the certified body.
- Early discovery of potential failures and their mitigation.
- Planning and execution of pre-testing in our own facility.
- Participating in certification testing and following up as appropriate.
- Documentation capture and deliverables to system release process.
- Responsibility for maintaining certification status, including implementation of design changes with manufacturing partners.
The position may well evolve according to the wishes and ambitions of the successful candidate. You should also expect tasks somewhat outside your field of expertise – one of the wonders of joining us this early. Finally, being a participant in activities across country borders, we expect a certain amount of travel, on the order of 20 days per year.
Your Profile
The ideal candidate will possess most of the following qualifications:
- Engineering degree at M.Sc level in electronics or other relevant field of engineering.
- 5+ years of experience with medical electrical system certification, including EMC and electrical safety.
- Documented expertise within the standards governing medical devices, e.g. ISO14971, IEC60601-1, etc.
- Excellent communication and documentation skills -- English at business level, and generally comfortable in an international atmosphere.
- Excellent at creating and maintaining cross-functional working relationships.
- Some understanding of the medical imaging product domain, e.g. Dental X-ray or CT scanning devices.
Most importantly, you are passionate about providing high-quality and innovative solutions, and enthusiastic about the possibility of working with skilled colleagues across the organization to influence the future of dental imaging.
To put it simply, we will prioritize energy, can-do attitude, and motivation over the number of years you have been in business.
We offer:
- Professional challenges in a highly dynamic and globally oriented business environment.
- Experienced and skilled colleagues.
- The chance to influence the next generation of 3D Dental X-ray scanner solutions.
- Open, honest, and constructive work environment.
- Competitive salary and benefits package.
- A unique opportunity to join the technical and commercial build-up of a new business area.
