Bachelor's /Master's degree in electrical engineering , Electronic Engineering, Mechanical Engineering, Computer Science Engineering OR Vocational Education in Information Technology or equivalent.
6+ years of experience successfully developing complex medical devices (hardware, software, consumables) products for acute care/hospital markets is necessary .
Hands-on experience (technical) in ventilation is a plus .
Knowledge of Statistical Data Analysis is necessary . Includes a bility to critically evaluate proposed study designs with basic knowledge of statistics, the calculation of sample sizes and/or estimation of statistical power .
Experience with conducting cross-discipline feasibility and trade off studies to evaluate electronic, mechanical, and pneumatic performance from subsystem to system level for issue resolutions
Solid understanding of System Verification and Validation test plan/protocols , executing V&V activities, generating, and analyzing test reports
Exposure to automation, Understanding of lab setup, qualification & equipment usage
U nderstanding of global medical device regulatory environments and clearance processes.
Effective communication , documentation, presentation, and interpersonal skills are required , as well as the ability to work both independently and as part of a team.
Experience auditing a DHF (Design History File - a compilation of records which describe the design history of a finished device) for compliance with internal processes and external standards.
Ability to understand new concepts quickly and apply them accurately throughout an evolving environment and organize work assignments to meet established timetables.
Data-driven decision-making : ability to move teams through vague and complex situations. Present complex ideas in a simple manner to resolve issues.
Relentless focus on Quality and Transparency as an organizational value. Maintaining strict confidentiality of sensitive information.
