Job Description

We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. With $1.4 billion invested annually in R&D, our collaborative and diverse teams have the resources they need to drive new discoveries and do cutting-edge research and develop important applications and tools that help millions of lives around the world.





About company: Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, increasing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global teams of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com About team: Providing outstanding product development services to Thermo Fisher scientific global business units, is one of the essential functions of the India Engineering Center (IEC). This global research and development center, established in 2009, located in Banjara Hills, Hyderabad, with over 150 employees. We are a team committed to develop innovative and groundbreaking technologically sophisticated products ranging from laboratory equipment, analytical instruments, remote monitoring solutions, chromatography and mass spectrometry. We are proud of the work that we do at India Engineering Center thereby fulfilling our mission of making the world a healthier, cleaner, and safer place: About the Job: This is a Divisional role as Staff Engineer supporting both manufactured and OEM products for the Business Unit (BU). The Staff Engineer is responsible for facilitating and executing Testing and Validation strategies defined by the Cross Functional Team (CFT). This position assists customers by providing regulatory support as it applies to the use of business unit products and services. The Staff Engineer will ensure adherence to established processes, policies, and procedures of the company and external regulatory agencies Job Title: Staff Engineer Reports to: Manager R&D Job Track: Professional Position Location: IEC Hyderabad Number of Direct Reports: none Responsibility:

• Responsible for the coordination and implementation of testing and validation strategy and compliance programs through the review, consultation, training, and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing, etc.) to fulfill their business goals in a compliant manner.
• Responsible for interacting with Cross Functional Team (CFT) network of people and resources in the business unit and provide general regulatory testing support in the regions and time zones where BU facilities operate, also, provide additional review and consultation for regulatory needs from centers of compliance excellence.
• Responsible for providing regulatory assistance in executing New and Existing Product Development projects (medium complexity level), monitor and manage timelines that are in test lab\xe2\x80\x99s control, and provide a regular update to project stakeholders.
• Collaborate closely between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, etc.) and ensures this interaction follows the established best practice model for the division.
• Responsible for review and sign off of testing and validation reports prepared by lab staff.
• Maintaining the test Laboratory with National level Accreditation Quality management system procedure in accordance with NABL ISO/IEC 17025:2017 Quality system. Also, as per A2LA and iLAC MRA accreditations.
• Ensure all testing activities for the project are performed conforming to the standard requirements.
• Participating Internal and External Audits as per lab Quality Management System (QMS) policy.
• Assist in departmental SOP development and adhere to Quality Management System requirements
• Participates in risk-benefit analysis for regulatory compliance
• Act as a change agent for improvement initiatives and facilitate finding a better way every day
• Perform all job duties in a safe manner and obey all safety policies and procedure
• Act in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement, and Innovation)

• Graduate degree in Science or Engineering
• 10+ years of experience in EMC testing of Laboratory products / medical device or any other regulated industry
• Shall have a minimum of 7 years of experience in testing and validation requirements of product, processes, and procedures.
• Experience in product compliance or product stewardship 3-5 years either in industry or at a Nationally Recognized Test Lab
• Solid understanding of the applicable product safety standards and how to apply them effectively
• Detailed understanding of IEC/EN 61326-1, IEC/EN 60601-1-2, CISPR 11, FCC part 15 ICES-001 and other basic EMI / EMC standards.
• Knowledge on using RF instruments such as signal generators, RF amplifiers, spectrum analyzers, EMI receiver, antennas, probes, ESD equipment, CDN, etc.,
• Knowledge on ISO/IEC 17025:2017 accreditation procedure and documentation.
• Knowledge on iLAC MRA and A2LA accreditation would be added advantage.
• Sound knowledge on Measurement uncertaininty calculation
• Hands-on experience in participating audits in accordance with ISO/IEC 17025

• Able to work independently without supervision
• Able to communicate effectively, written, and oral, with both technical and non-technical colleagues.
• Self-Motivator, Does not accept \xe2\x80\x9cwaiting for a response\xe2\x80\x9d. Must work with respective stakeholder to acquire the vital information and drive a project forward
• Must be a Problem Solver; Identifies problems and reviews related information to develop and evaluate options and implement solutions.
• Able to manage parallel projects and sometimes competing deliverables to meet project delivery dates.
• A team player willing to support and guide peers in analyzing and solving challenges