Head of Product Engineering

Bigetc Laboratories, a wholly owned subsidiary of Molbio Diagnostics, is seeking an experienced and visionary leader to establish and lead the Production and Process Engineering Team (PET) at its Bangalore Research and Development facility. This Head will lead the industrialization of new IVD products (e.g. assays, instruments) by developing scalable, validated, and compliant manufacturing processes. This individual will manage a multidisciplinary team to ensure seamless transfer of products from Design and Development. This includes understanding and oversight of pilot manufacturing, transfer of pilot scale manufacturing to the Molbio manufacturing sites, working with Manufacturing to set up automated production lines, process optimization and validation, and scale-up to required manufacturing levels.

The Head will also be responsible for environments such as ISO 13485 and FDA QSR.

Key Responsibilities:

Strategic and Technical Leadership

● Lead the Production and Process Engineering Team to establish scalable, robust, and efficient manufacturing processes for reagents, consumables, and instruments, including the automation of processes.

● Build, mentor, and manage a high-performance team including process engineers, equipment engineers, documentation specialists, and maintenance staff.

● Design and implement robust production engineering processes to support new product introduction (NPI), scale-up, and sustained manufacturing.

Production Engineering Strategy & Execution

● Co-own the transfer of products from Design and Development to Manufacturing in alignment with ISO 13485 clause 7.3.8. (Design and Development is the ultimate owner).

● Oversee process design, optimization, and validation (IQ/OQ/PQ) for pilot and full-scale production.

● Drive process design, optimization, and technology transfer from Design and Development to Manufacturing.

● Lead initiatives in design for manufacturability (DFM), process validation, and continuous improvement and troubleshooting.

● Lead the implementation of automation and lean manufacturing practices.

Compliance & Quality

● Ensure all production engineering activities comply with ISO 13485, GMP, and other applicable standards.

● Collaborate with Quality, Regulatory, and Validation teams to develop and execute qualification protocols, procedures and reports as required (IQ/OQ/PQ).

● Ensure all processes are documented in accordance with the Quality Management System.

● Drive continuous process validation and quality improvement initiatives.

Equipment & Automation

● Plan and oversee the selection, procurement, installation, and validation of production equipment and automation lines.

● Define preventive maintenance programs and drive OEE improvements.

5. Cross-functional Collaboration

● Work closely with Design and Development, Manufacturing, Quality Assurance, Supply Chain, and Regulatory Affairs to ensure seamless product scale-up.

● Act as the engineering voice in core product/project and technical and phases review meetings.

6. Cost and Efficiency Optimization

● Implement lean manufacturing, value engineering, and Six Sigma principles to reduce cost and improve efficiency.

● Drive root cause analysis (RCA) and corrective/preventive actions (CAPA) for production- related issues.