job description
Join Cochlear, a global leader in implantable hearing solutions, as a Senior Validation Engineer in our dynamic team based in Bali, Indonesia. In this pivotal role, you will drive the validation of cutting-edge manufacturing processes, state-of-the-art equipment, and critical test systems to ensure compliance with the highest quality standards and regulatory requirements (ISO 13485, FDA 21 CFR Part 820).
As part of our mission to help people hear and connect with the world, you will collaborate with cross-functional teams to validate processes that directly impact the safety and efficacy of our life-changing hearing implant technologies. This is a unique opportunity to contribute to a purpose-driven organization while advancing your career in medical device validation.
Based in the vibrant hub of Denpasar, youâll enjoy a work-life balance in one of the worldâs most sought-after destinations, combining professional growth with the unparalleled lifestyle of Bali.
Responsibility
- Develop, execute, and document validation protocols (IQ, OQ, PQ) for manufacturing processes, equipment, and test systems in accordance with GMP, ISO 13485, and FDA regulations.
- Lead risk assessments (FMEA, HAZOP) and design control activities to ensure product and process compliance.
- Collaborate with R&D, Production, and Quality teams to implement process improvements and troubleshoot validation deviations.
- Prepare and maintain validation documentation, including reports, SOPs, and technical files for regulatory submissions.
- Conduct data analysis and statistical evaluations to verify process capability and consistency.
- Support audits (internal/external) and ensure timely resolution of non-conformances and CAPAs.
- Train and mentor junior engineers on validation methodologies and best practices.
- Stay abreast of industry trends and emerging regulations in medical device validation.
Qualifications
- Bachelorâs or Masterâs degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related field.
- Minimum 5 years of experience in validation engineering within the medical device or pharmaceutical industry.
- In-depth knowledge of GMP, ISO 13485, FDA 21 CFR Part 820, and EU MDR.
- Proven experience with validation protocols (IQ/OQ/PQ), risk management (ISO 14971), and statistical tools (Minitab, JMP).
- Strong technical writing skills for validation documentation and regulatory submissions.
- Familiarity with cleanroom environments, sterilization processes, and automated test systems.
- Excellent problem-solving, communication, and project management skills.
- Certification in Six Sigma, Lean Manufacturing, or ASQ CQE is a plus.