Manager-Pilot Lab Operations

MyCareernet; Bengaluru; On-site; INR 1,500,000 - 2,000,000; Full time

Job summary

A leading company in medical device development seeks a skilled professional to manage pilot line and NPI lab operations. The ideal candidate will have extensive experience in complex product development, regulatory compliance, and ERP systems. Responsibilities include defining pilot build scopes, managing operations, and maintaining quality standards. Candidates should hold a relevant degree and possess strong analytical skills. This position requires the ability to lift equipment and may involve occasional travel.

Qualifications

• Must have experience with complex product development, including developing and integrating complex instrumentation systems.
• Understanding of production, prototyping, and fabrication processes.
• Demonstrated ability to understand and comply with applicable FDA regulations.

Responsibilities

• Define scope, schedule pilot builds, and track progress using ERP systems.
• Manage Pilot Line and NPI lab operations for prototype and pilot builds.
• Develop and maintain process Failure Modes and Effects Analyses for new product builds.

Skills

NPI

Quality PFMEA

DFMEA

SFMEA

Pilot plant

New Product Development

ERP System

Medical Device

Education

Bachelor's degree with 9+ years of experience or Master's degree with 7+ years

Tools

SAP

Oracle

Job description

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