Company Description Emarlex Multiventure is an IT services, HR consulting, and business solutions company that helps organizations accelerate growth through technology, talent, and digital transformation. The company partners with startups, SMEs, and large enterprises to build high-performing teams, streamline HR operations, and implement modern business technologies.

Its service portfolio includes IT consulting, HRMS implementation, permanent and contract staffing, recruitment process outsourcing, executive search, payroll processing, and HR operations support. Emarlex specializes in recruiting skilled professionals across domains such as software development, AI and generative AI, data science, cloud, cybersecurity, ERP, manufacturing, BFSI, healthcare, sales, and leadership. With a customer-first approach, Emarlex delivers scalable solutions that enable clients to hire smarter, operate efficiently, and grow with confidence.

Role Description The Codes and Standards Engineer – Medical Devices will ensure that medical device designs, materials, and manufacturing processes comply with relevant international and regional standards, regulations, and industry best practices. In this full time, on-site role based in Bengaluru South, the engineer will interpret and apply standards (such as ISO, IEC, FDA, and other medical device regulations), support product design teams with compliance requirements, and contribute to risk management and safety evaluations.

Day-to-day responsibilities include reviewing technical documentation, conducting gap analyses against applicable codes,



coordinating testing and certification activities with external labs and regulatory bodies, and preparing compliance reports. The role will also involve collaborating with quality assurance, R&D;, and regulatory teams to maintain up-to-date knowledge of evolving standards, supporting audits, and recommending design or process changes to ensure continuous compliance.

Qualifications

- Strong knowledge of medical device regulations, standards, and codes (e.g., ISO 13485, ISO 14971, IEC 60601 series, FDA 21 CFR), with experience interpreting and applying them to product development.
- Experience in engineering design and development for medical devices, including familiarity with product lifecycle, design controls, verification and validation, and documentation best practices.
- Background in quality systems and regulatory compliance, including risk management, audits, nonconformance handling, and corrective and preventive actions (CAPA).
- Ability to collaborate with cross-functional teams (R&D;, Quality, Regulatory, Manufacturing) and communicate complex standards and regulatory requirements clearly to technical and non-technical stakeholders.
- Bachelor’s degree or higher in Biomedical Engineering, Mechanical Engineering, Electronics Engineering, or a related discipline; relevant certifications in regulatory affairs or quality management are an advantage.
- Analytical mindset with strong attention to detail, structured problem-solving skills, and the capacity to manage multiple projects and deadlines.
- Prior experience working with testing and certification agencies, preparing technical files,

📌 Codes And Standards Engineer – Medical Devices (Bengaluru)
🏢 Emarlex Multiventure
📍 Bengaluru