Join one of the most promising company in the Swiss Medtech environment!
Abionic is committed to revolutionize the world of in vitro diagnostics with rapid universal point-of-care solutions. Based on disruptive technology, Abionic is offering the world of healthcare a novel point-of-care diagnostic tool and thereby fills patients’ unmet needs.
Abionic is an innovative company located in the Lausanne area, Switzerland. It is ideally positioned at the boundaries of medical technology, biotechnology and nanotechnology. Abionic is a fast-growing company with ambitious objectives, spin-off from EPFL and a proud member of Health Valley Switzerland.
We are looking for an NPI Engineer to complete our team.
To join our New Product/Process Introduction (NPI) team, we are looking for an engineer who is motivated to bring his/her expertise and experience to our company. In this key role, your tasks will be to:
- Actively participate in the development of new products to ensure compatibility with current and future manufacturing processes and capabilities in compliance with our internal Quality Management System, under the ISO 13485 standard.
- Partner with R&D team to assess manufacturability throughout the life cycle of new nanofluidic immunoassay products.
- Coordinate and/or execute experiments and analysis of data in line with NPI project plan and deliverables. This consists in particular in operation-related activities required for the transfer of new product to routine production, i.e.:
- Process / Test method development and validation
- New equipment qualification
- Process improvement and optimization
- Production scale-up
- Develop and maintain production and QC documentation including work instructions, product specifications and traceability reports.
- Use technical knowledge to troubleshoot assay design challenges encountered during the course of assay development, clinical validation or manufacturing validation.
- Support the Quality Control and Production teams in resolving investigations related to non-conformities and performing activities related to CAPA.
- Master’s degree in Life Sciences (or related) with 1+ year of relevant experience in medical device, diagnostic or biomedical industries.
- Practical experience with immunoassay or other protein biochemical techniques is a plus.
- Knowledge of Design Controls is a plus.
- Working under a Quality Management System, with practical knowledge of the ISO 13485 standard is a plus.
- Ability to prioritize, manage multiple tasks with agility to deliver timely results.
- Ability to take decisions without full dataset, on a risk-based approach.
- Ability to perform work independently and in cross-functional team, in a fast-paced environment.
- Sense of responsibility and ownership.
- Good computer skills.
- Excellent oral and verbal communication skills, mastery of technical writing.
- Language requirement: Fluent French with good command of English (at least B2 level), or excellent English (both oral and written).
She/He must be motivated to contribute to the development of a highly innovative company as part of our young, talented and ambitious team.
A challenging job within an exciting modern environment within a MedTech company, Integration in a dynamic team, A highly innovative environment, An opportunity to improve healthcare.
Starting date: Immediately
Activity rate: 80-100% (to be discussed)
You want to work in an innovative environment and to integrate a dynamic team?
Please send us your application (CV, cover letter, and work certificates when applicable) to firstname.lastname@example.org, indicating “NPI Engineer position” in the headline.