Biocompatibility Engineer

S2S Soft is a Global IT Solutions and Services company with unmatched expertise spread across various Industrial Internet like IT Staff, Document Management, Software Development, Mechanical Design and Independent Software Vendors. Our clients have relied on us for providing Technology initiatives and support for their business processes in the areas of Enterprise Application Management, Custom Application Management, Business Intelligence & EAI, Infrastructure Management & Security and Quality Assurance & Testing Services.S2S Soft understands the unique challenges faced by various industries. Through hands on experience earned from different client engagements, we enable our customers to address their challenges with tailor made solutions best suited to their present systems. With a firm eye on Return on Investments of our customer, we conceive, build and deploy solutions that are robust, scalable and yet flexible. We partner with our clients on their long-term initiatives by providing real value while demonstrating high level of professionalism and ethics metus. Please send your resume to for immediate consideration

• A bachelor or master’s degree with a discipline in Toxicology, Chemistry, Biochemistry, Biomedical Engineering, or equivalent
• 4-8 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations
• Experience of applying the principles, theories, and concepts in biocompatibility per ISO 10993/18562 - Understanding of FDA and ISO 10993 biological safety requirements and/or test methods
• Working knowledge of Good Laboratory and Good Manufacturing practices (GLP and GMP). - Experience in Cleaning, Sterilization and Biocompatibility in a medical device setting.
• Liaising with contractors and external suppliers.
• Experience with auditing and reporting procedures
• Understanding of Healthcare/Medical Devices domain related compliance standards and regulations
• Knowledge of Product Lifecycle Management
• Prior experience independently developing biological safety assessments for inclusion with regulatory submissions is preferred
• Knowledge of standards for biocompatibility of breathing gas pathways in healthcare applications, e.g. ISO 18562, is preferred
• Industry experience in medical device materials and product development is preferred
• Experience in supporting regulatory submissions, namely 510ks, is preferred
• Experience working with internal and external scientific standard organization (e.g. ISO/TC 194) is preferred
• Strong cooperation with cross functional teams
• Deliver biocompatibility assessments and biocompatibility evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework
• Collaborate with a cross-functional team to support multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules
• Analyse biocompatibility test results to determine adequacy of data to meet requirements for the biological effects and utilize problem solving skills and technical knowledge to troubleshoot unexpected results
• Assist with regulatory submissions to global regulatory agencies in order to elaborate on the ResMed product biocompatibility strategy and data in response to additional information requests
• Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports
• Learn and maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices
• Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on ResMed products and business
• Identify part information and perform analysis for biocompatibility evaluation assessments - Comply to process requirements and meet standards