DESCRIPTION
As part of a distributed team the ideal candidate brings outstanding communications skills, excellent technical expertise and creative thinking to the organization.
Responsibilities:
- Create new firmware for life science instruments in a distributed and cross-functional team
- Maintain existing firmware for life sciences instruments
- Create and maintain software lifecycle documents
- Support the verification of firmware and systems
- Comply to the quality management system and applicable regulatory requirements
QUALIFICATION
- Bachelor or higher degree in CS, EE, or related field
- 7 years of experience in developing firmware in C or C in the Life Sciences or Medical Devices field
- Experience in analysing system requirements and deriving firmware requirement and creating a firmware architecture that meets the needs
- Proven experience in working successfully in Agile, e.g. Scrum or XP, teams
- Experience in using a real time operating systems, e.g. ThreadX, is a plus
- Familiarity with 21 CFR, Part 820, IEC 62304, ISO 13485 and ISO 14971 highly desired
- Experience in LC-MS or CE systems is a plus
- Excellent communication skills
- Strong business sense
- Excellent problem solving skills
- Highly motivated to improve continuously
- Results oriented independently and in a team setting– has track record for delivery results, takes ownership and is accountable