Responsibilities:
Leading all electrical and mechanical hardware aspects for medical device:
Prepare and perform development and testing by defining technical requirements, test strategies and test equipment.
Translate standard requirements to HW requirements.
Architecture definition.
Design specifications.
Test moderate to highly complex medical equipment and ensure product meets regulatory compliance requirements.
Documentation.
Evaluate the effectiveness of the design and change if necessary.
Estimate cost, reliability, and safety factors.
Work closely with Quality and Regulatory team to ensure conformance to established design development processes and procedures.
Participate in setting technical direction, plan schedule and coordinate detailed phases of the project.
Prepare and perform development and testing by defining technical requirements, test strategies and test equipment.
Liaise with global laboratories to ensure consistency and accuracy of methods and interpretations.
Analyze test data and determine expected outcome for tests.
Document test results and deviations for correction actions, reports, and audits.
Conduct root cause HW analysis to determine design or other weak spots in existing system design that affect reliability and robustness.
Provide processes, tools, and education for field engineers, as well as diagnosis of HW issues in the field.
Required Qualifications:
Electrical or HW engineer – B.Tech. / B.Sc. / M.Sc.
Proven experience in passing standard testing in authorized certification labs.
Proven experience in Hardware system integration
Hands on experience in hardware testing and firmware verification.
Familiarity with different technologies and cables interfacing between HW components.
Technical documentation writing and troubleshooting skills.
Excellent English communication skills (written and spoken)
Required Skills:
Independent and autodidact personality
Drive decision making among relevant stakeholders on key topics.
System level understanding, ability to approach complex issues with curiosity and determination.
Team player
Creative thinker
Process and quality oriented
Experience from medical industry- Advantages
