Certifier II (Medical Devices)

CSA Group; Bengaluru; On-site; INR 900,000 - 1,200,000; Full time

Job summary

CSA Group in Bangalore is seeking a Product Safety Certifier II to provide high-quality certification for Medical Devices according to applicable safety standards. The role requires managing multiple projects, evaluating products against standards, and collaborating with clients to support their certification needs.

The ideal candidate holds a Bachelor’s Degree in Engineering with at least 5 years of experience or a Diploma with 7 years. Expertise in X-Ray standards and knowledge of TIC processes for Medical Devices is essential.

Qualifications

• Minimum 5 years of related experience with a Bachelor’s degree or 7 years with a diploma.
• Experience in Test, Inspection, and Certification (TIC) within Medical Devices.

Responsibilities

• Independently manage multiple certification projects.
• Evaluate products against national and international standards.
• Collaborate with sales to support clients and develop new opportunities.

Skills

Knowledge of safety standards for North America

Expertise in X-Ray standards

Understanding of Risk Management for medical equipment

Education

Bachelor’s Degree in Engineering

Diploma in Engineering

Job description

Job Summary

Product Safety Certifier II (Medical Devices) – CSA Group, Bangalore. This role provides high‑quality certification in accordance with Medical Device product safety standards (e.g., IEC/ANSI AAMI / CSA 60601‑1 and its collateral and particular standards), with a primary focus on X‑Ray related standards (60601‑1‑3, 2‑28, 60601‑2‑43, 60601‑2‑45, 60601‑2‑54). The position involves interpreting standards, processes, and procedures, making technical decisions, and maintaining the integrity of CSA’s global certification programs.

Responsibilities

• Independently manage multiple certification projects, ensuring compliance with applicable safety requirements and meeting time and cost targets.
• Evaluate products against national and international standards and precedent decisions.
• Handle a wide spectrum of projects, including complex high‑revenue assignments, and deliver results within agreed timeframes.
• Maintain project costs within budget and meet productivity expectations.
• Review the work of others per divisional quality documents and perform witness testing as required.
• Review test data and reports, authorize the use of the CSA Mark, and prepare or sign Certification Reports and Certificates of Compliance.
• Assist clients in solving problems or failures without disclosing proprietary information.
• Collaborate with sales to support current clients and develop new opportunities; prepare project quotations and explain certification programs and production control requirements.
• Prepare Test Lab Work Orders and Special Testing Documentation, including sample plans, data collection methods, tables, Job Hazard Analysis, and instructions.
• Guide Lab Technicians to ensure proper application of requirements and data collection methods.
• Perform common testing within CSA laboratories and conduct field trips to witness test work at manufacturer facilities.
• Participate in internal audits for compliance and competence, and contribute to CSA Group Continuous Improvement and Innovation projects.
• Recommend new programs or equipment to expand core capabilities and generate ideas to improve laboratory safety.
• Develop comprehensive knowledge of all national and international standards through research of standards, documentation, bulletins, and technical articles in the area of specialty.
• Recommend revisions to ensure technical consistency and resolve issues of pertinent practices, processes, and precedents.

Education and Experience

• Bachelor’s Degree in Engineering with at least 5 years of related experience, or Diploma in Engineering with at least 7 years of related experience.

Must-Haves

• Thorough knowledge of safety standards for North America, Canada, and IEC, especially Medical Devices and testing procedures.
• Expertise in X‑Ray standards (60601‑1‑3, 2‑28, 60601‑2‑43, 60601‑2‑45, 60601‑2‑54).
• Some experience in Test, Inspection, and Certification (TIC), ideally within Medical Devices; manufacturing background considered.
• Understanding and application of the Risk Management concept for medical equipment.

Preferred

• Knowledge of CSA certification programs and services applicable to a variety of equipment.
• Experience with competitor programs or relevant industry experience.

Equal Opportunity Statement

CSA Group is an Equal Opportunity Employer committed to diversity, equity, and inclusion. We prohibit discrimination and harassment on the basis of any protected class in accordance with applicable laws. Opportunities are based on skills and abilities, and differences are respected and valued.

Contact for Accommodation

Please contact [e-mail] if you require accommodation during the interview process.