Our client is looking for a system engineer that can support a growing company and be in on an exciting opportunity.
- Pull together client requirements, and help company engineers convert those into system requirements, and come up with specifications to meet those requirements.
- Candidate needs to know FDA class 2 devices – 510k submissions, be someone that drives risk documentation/risk control measures, understanding of those measures and performs validation process with the measures.
- Must be able to understand work in development, put rational order and have an understanding of ISO 14971 and 13485 requirements (software devices).
- Technical Writing experience, (especially software with medical devices is a plus).
- Degree required
- Experience with medical devices and specifically software as a medical device, including documenting and managing customer requirements (user needs), system requirements (inputs) and system requirement specifications (outputs).
- Experience with risk management, human factors analysis, project leadership.
- Comfort in start-up environment (fast-paced, fluid responsibilities, changing priorities).
- INCOSE (international council on system engineering) membership is a plus
M Force Staffing is an equal opportunity employer. All qualified applicants, including individuals with disabilities and protected veterans, are encouraged to apply. In addition to federal law requirements, M Force Staffing complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. M Force Staffing is an E-Verify Employer