Website:
mycareernet.in
Job details:
Key Skills: Npi, Quality Pfmea Dfmea And Sfmea, Pilot plant, New Product Development, ERP System, Medical Device
Roles and Responsibilities:
- Define scope, schedule pilot builds, allocate equipment and lab space resources, and track progress using ERP systems (SAP or Oracle)
- Manage Pilot Line and NPI lab operations to support prototype and pilot builds, ensuring throughput metrics are met
- Perform instrument decontamination and execute failure analysis investigations using industry-standard reliability and compliance protocols (e.g., ISO, FDA)
- Develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for new product builds and concepts
- Create and update design control documentation, product configurations including Device History Records (DHRs) and Bills of Materials (BOMs), in compliance with Quality System Regulations
- Capture and analyze build findings to support process and product improvement projects in collaboration with R&D and Quality engineering teams
- Ensure adherence to regulatory standards (FDA, ISO 13485, IEC 62304) across pilot builds, documentation, and lab operations
Skills Required:
- Must have experience with complex product development, including developing and integrating complex instrumentation systems
- Utilize your understanding of production, prototyping, and fabrication process and the time, cost, and quality tradeoffs to support the function and growth of the team
- Demonstrated ability to understand and comply with applicable FDA regulations and Company operating procedures, processes, policies and tasks
- Available for periodic travel (10-25%) to support manufacturing operations, process implementation, and cross-functional collaboration across multiple sites.
- Must have a valid driver's license with an acceptable driving record
- Ability to lift, move or carry equipment up to 25 lbs, any other physical requirements
It would be a plus if you also possess previous experience in:
- Experience and knowledge of ISO/FDA-regulated industry.
- Medical Products industry experience.
Education: Bachelor's degree with 9+ years of experience OR Master's degree with 7+ years of related work experience. Degree in relevant fields such as Physics, Applied Physics, Biology, Bioengineering, Biomedical Engineering, Mechanical Engineering, Fluidics
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