Bio-compatibility Engineer
Tata Elxsi · Posted Nov 4
Design and technology services, product engineering, systems integration, and digital transformation solutions
Get a personal compatibility score
Add a resume for personal matches
About the role
Tata Elxsi’s Biocompatibility Domain supports medical device clients with biological safety evaluations, biocompatibility documentation, and regulatory compliance in FDA/ISO regulated environments. The role involves authoring biological evaluation plans and reports, reviewing material and analytical data, supporting contract testing, and conducting toxicological risk assessments under ISO 10993 and other international standards. The engineer collaborates with cross-functional teams on gap assessments, regulatory interpretations, and project delivery.
What you will do
- 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.
Skills used in this role
What the employer is looking for
- Minimum bachelor’s degree in relevant discipline.
- Experience : 3 to 12 Years
- 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.
Preferred qualifications
- 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 environment.
- 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
Benefits and support
- Compensation and benefits are detailed in the job posting
About Tata Elxsi
Tata Elxsi is a global provider of design-led technology services, specializing in product engineering, systems integration, and digital transformation. Operating across sectors like transportation, healthcare, and media, the company combines design thinking with advanced technologies such as AI, cloud, and IoT to help enterprises build connected, intelligent products.
- Industry
- Design Services
- Company size
- 11500+ employees
- Founded
- 1989
- Location
- Bengaluru, India
- Funding stage
- Public Company
Funding
Public Company · $0 raised
Leadership
Manoj Raghavan
CEO & Managing Director
Nalin Rana
Chief Financial Officer
Recent coverage
The Economic Times
Tata Elxsi Q2 Results: Profit rises 10% YoY to Rs 170 crore; revenue grows 15%2026-10-13
Tata Elxsi
Tata Elxsi Invests in KAVIA AI to Scale AI-Driven Software Engineering for Products and Enterprises2026-09-10
Tata Elxsi
SCTIMST and Tata Elxsi Forge Strategic Partnership to Accelerate Healthcare Innovation and Medical Technology Development2026-07-27
Tata Elxsi
Tata Elxsi and Sarla Aviation Partner to Accelerate Development of Shunya, India's First Indigenous eVTOL Aircraft2026-10-13