Positions: Biocompatibility Engineer/Senior Engineer/SME

Position Summary:

The Biocompatibility Author/ Engineer is primarily responsible for authoring biological evaluation plans and reports as well as assisting with gap assessment. The individual is responsible for reviewing material & analytical data, supporting external contract testing programs as well as supporting toxicological risk assessments in accordance with ISO 10993 and relevant international standards. The individual will work closely with program/project cross-functional teams.

The author supports TATA ELXSI’s Biocompatibility Domain to strengthen the existing capabilities, and competencies and develops new domain capabilities.

Must have:

Basic technical knowledge in biocompatibility/toxicology and a general understanding of material, physical and chemical properties of common materials used in medical devices.

Basic technical knowledge of ISO 10993-1, EU MDR and US FDA guidelines regarding biocompatibility.

Ability to understand and apply global regulatory guidelines including OECD, FDA GLP, GMP, ISO 10993 series, ISO 17025, USP pharmacopeia, and regional compendia.

Basic knowledge of Microsoft Office Suite (Word, Excel, Teams, and PowerPoint). Other preferred software: SharePoint and DocuSign.

Good to have:

Understanding of medical device manufacturing processes, biocompatibility assessment methodology, and biocompatibility endpoint testing methodology.

Knowledge of international standards relative to QMS, labelling, packaging, sterilization, design verification, shelf life, test method validation, material validation, and process validation in relation to biocompatibility

Good understanding of the raw materials used for manufacturing medical devices.

Good understanding of medical terminologies and human anatomy.





Ability to recognize how to best interpret, summarize, and present information to ensure quality and accuracy of content in complex document types under general supervision.

Basic knowledge in Tech doc compilation and notified body submission.

Ability to apply effective interpersonal, verbal, and written communication skills.

Ability to work independently and in a multi-cultural team workplace.

Must be team-oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact in the highest professional manner with all organizational levels

Role and Responsibilities:

Participate and support the gap assessments of products by reviewing legacy documentation and evaluating devices to determine the applicability of test data to ISO 10993 standard.

Participate in biocompatibility strategies discussion and prepare a biological evaluation plan/report and risk assessment in consideration of gaps in materials, design, and process to achieve optimal solutions that satisfy timeline, cost, and technical requirements.

Assist in an assessment of medical device changes evaluation impacting the biocompatibility

Participate and prepare interpretations of standards, test methodology, and perform regulatory standards’ gap evaluation.

Analyze, interpret, and draw conclusions from existing biocompatibility testing, as well as extractable and leachable chemical characterization data.

Collaborate with associates of diverse technical backgrounds and partners with Regulatory Affairs, Quality Engineering, Manufacturing, Packaging, and Project Teams, to achieve desired project outcomes

Ensure compliance with the client’s and internal training, Standard Operating Procedures (SOPs), Work Instructions (WIs), and guidelines.

Should assist the Team Lead/Manager to ensure scheduled delivery.

📌 Biocompatibility SME (Bengaluru)
🏢 Tata Elxsi
📍 Bengaluru