What are the responsibilities and job description for the Process Engineer position at Novozen Healthcare LLC?
Process Engineer
Job Summary :
We are seeking a Process Engineer to support the scale-up of manufacturing processes for complex electromechanical medical devices. The ideal candidate will have a strong background in medical device manufacturing, risk assessment, and process optimization. This role will focus on developing, validating, and implementing efficient processes while ensuring compliance with industry regulations.
Key Responsibilities :
- Lead process development activities for scaling up the production of electromechanical medical devices.
- Perform risk assessments (such as FMEA) to identify potential failure modes and improve process reliability.
- Develop and optimize Standard Operating Procedures (SOPs), Work Instructions (WIs), and process validation documentation to ensure robust manufacturing workflows.
- Collaborate with cross-functional teams including R&D, Quality, and Manufacturing to ensure seamless process transitions from development to production.
- Conduct process validation activities including IQ / OQ / PQ to ensure compliance with FDA, ISO 13485, and GMP standards.
- Implement lean manufacturing and process improvement initiatives to enhance efficiency and reduce costs.
- Troubleshoot process issues and implement corrective and preventive actions (CAPA) as necessary.
- Ensure all process documentation is up to date and meets regulatory requirements.
Qualifications & Experience :
