TESTING ENGINEER
- Bangalore, Karnataka
- Permanent
- Full-time
- Perform tests for Imaging (CT, MRI, PET, X-Ray, Mammo, C-Arm, Bone Densitometer) & Patient care solutions products (Anesthesia & Respiratory Care, Ventilators, Incubators, Baby Warmers, Fetal Monitoring Systems, Bedside Monitors, Central Stations, ECG Machines).
- Execute EMC, Safety & Environmental test plans for medical devices, ensuring they meet the requirements of standard IEC 60601-1, IEC 60601-1-2 and related EMC standards, Environmental Standards.
- Hands on experience for Conducting various EMC tests, including conducted emission (CE), radiated emission (RE), conducted susceptibility (CS), and radiated susceptibility (RS) tests, as well as ESD immunity testing.
- Hands on experience for Conducting various Safety, Thermal & Vibration testing per submitted Test Plans and applicable standards.
- Analyze test data, identify potential issues, and work with engineering teams to implement design changes and resolve compliance problems.
- Support team for external agencies Certification (CTF) / accreditation (NABL) of the Lab’s.
- Stay current on relevant standards and assess laboratory impacts of changes and additions, simplify where possible.
- Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Keep up-to-date on knowledge and understanding of current regulatory requirements for test laboratory within area of responsibility to ensure laboratory accreditations are maintained
- Complete all tests in compliance with procedures and regulations
- Complete all planned Quality & Compliance training within the defined deadlines
- Identify and report any quality or compliance concerns and take immediate corrective action as required
- Effectively support implementation & training of current regulatory requirements
- Bachelors in Electrical / Electronics
- 1 ~ 5 years of relevant industrial experience in the regulated medical device industry or similar industry.
- Experience in Design & Development, Testing, Qualification, Certification of the Products with IEC or equivalent standards.
- Working knowledge of Safety & EMI/EMC regulations: IEC 60601-1, IEC 60601-1-2 Collateral and Particular.
- Knowledge of Quality Management Systems including IEC/ISO 17025, Lab Accreditation & Certification.
- Excellent team-player skills w/global mindset
- Excellent interpersonal, organizational, communication and influencing skills
- Working knowledge of GEHC products
- Ability to manage multiple activities effectively.
- Ability to communicate effectively with engineers from different disciplines and varying levels of experience.
- Strong people networking skills.
- Clear thinker, action oriented, high energy, self-starter.
- Effective team player with motivating skills.
- Strong working knowledge of English language (oral and written)
- Previous experience in an ISO/IEC 17025 accredited lab
- Knowledge of process improvement tools (six sigma, lean, ISO, TQM)
- Strong organizational skills with high attention to detail
- Adaptable/Flexible: Being open to change in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations