Job Description Summary

Primary focus of this position is to support optimizing, implementing, and validating components/elements of a medical device. The candidate will assist in conducting design and process qualification and validation; assist/write technical documents, validation protocols and reports; perform/coordinate hands-on testing of a device; assist in failure investigations; and support other activities from R&D, Quality, Operations, and Regulatory Affairs.

Job Description

Essential / Key Job Responsibilities (including supervisory and/or fiscal):

1. Design: serve as subject matter expert of components of a medical device, including design evaluation for proposed changes to materials, processes, suppliers, tolerances, clinical use scenarios and international standards.

2. Process Validation: assists in the development and review of process validation (IQ, OQ, and PQ) to qualify process and design changes, using statistical methods and software as appropriate.

3. Documentation: write protocols, technical documents, and reports. Prepare and edit raw material specifications and drawings. Assist in preparing verification and validation protocols and reports. Review and update documents such as Design Input Requirements, Design History File, and End Item Specification

4. Test Method Development: develop engineering test methods and clinically relevant simulated use test methods in conjunction with R&D technicians; prepare and assist in the validation of test methods.

5. Testing: coordinate/perform lab bench testing, conduct engineering and competitor evaluations, assist with failure investigations, and verification and validation activities.

6. Training: train technicians on new design and process development as well as new test methods.

Other Responsibilities may include, however are not limited to:

• Assist in the support of Manufacturing, Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines.
• Assist in design and process root cause analysis and support non-conforming product and complaint investigations.

Required Qualifications:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.
• Experience: 3-5 years of industrial experience in R&D, quality, or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.
• Demonstrated hands-on technical aptitude.
• Experience in process validation (IQ, OQ and PQ), writing protocols and reports to support verification and validation activities for product commercialization; ability to assist in executing validation.
• Experience in creating and/or interpreting engineering drawings/specifications
• Excellent oral and written communication skills.
• Ability to work in cross functional teams.

Preferred Qualifications:

• Ability to analyze data, interpret results, and write reports. Proficient in statistic software is a plus.
• Knowledge of cGMP and GLP is a plus.
• Training in Six Sigma or Design for Six Sigma is a plus.

Education and/or Experience:

• B.S. degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering or other related engineering discipline.   
• Experience: 3-5 years of industrial experience in R&D, quality, or process development, preferably in medical device or other regulated FDA/QSR and ISO environment.

Required Skills

Optional Skills

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Primary Work Location

IND Bengaluru - Technology Campus

Additional Locations

Work Shift