Description
The ideal candidate should have at least bachelors degree in biology/biomedical sciences/medical device technology and has at least 2, preferably 3 years of experience, but is at the beginning of his/her career. Additional courses, certificates is a plus.Below is a list of what we consider valuable for this position, and I will make a decision depending on the actual qualities of the candidates. The job title is based on the experience level. There is strong advancement opportunity for the right candidate.
I would consider candidates with at least four characteristics from the following list, plus the additional requirement.
List of skills/experiences
Previous experience in the medical device industry, in one or more of the following areas:
- IVD assay development
- QC/Regulatory department
- software development and testing
- development of computer-controlled systems
Previous experience and working knowledge of the FDA Design Control procedures
Project management experience/skill set
Intermediate level statistical knowledge (focused on biostatistics and laboratory science)
Hands-on experience with operating automated instruments
Experience with microscopic methods, such as fluorescence or confocal microscopy
Proven written communication skills (authored SOPs, work instructions, manuals, procedures, regulatory submissions, reports, or similar)
Strong intellectual skills, proven troubleshooting skills and track record
Some supervisory experience
Advanced computer (at least Word and Excel) skills
"Leader" personality, embracing responsibility