The Sr. Manager, NPI Manufacturing Engineering, IDC is responsible for leading the efforts of multi-discipline Manufacturing Engineers in support of New Product Development and Sustaining Product design transfer to outsourced manufacturing partners. The core set of responsibilities covers the product design documentation and manufacturing test and tooling, including; purchase specifications, regulation compliance capture and labeling, assembly instructions, product release validation and lifecycle management deliverables within a healthcare compliant industry. A people leader that manages the engineering associates and their performance to the deliverable requirements and their associated professional development. Develops processes, implements, and monitors projects within the NPI team, adheres to timelines and budgets, procures capital equipment and tooling as required to support manufacturing efforts, and provides both technical and management leadership within the Product and Project Core Teams as a representative of NPI MFG Engineering to maintain DFx, and the successful transfer to manufacturing.
This position reports to the Sr. Manager, Global Manufacturing Engineering and is part of the Global Instrument Operations and Global Supply Chain Organization. This position is located in Bangalore, India and will be an on-site role.
In this role, you will have the opportunity to:
- Ensures that Manufacturing Engineering teams deliver the highest quality products and documentation using processes which consistently meet (or exceed) all applicable customer expectations; follows QSRs, FDA and ISO requirements; abides by company safety policies, practices and procedures; and is compliant with the latest regulations, globally.
- Represent Manufacturing Engineering in cross-functional teams and cultivate a network of support (Manufacturing, Quality, Sales, and Marketing) to facilitate completion of deliverables, utilizing internal and external resources as needed.
- Supervises daily operations of the Manufacturing Engineering department by providing leadership and direction, managing employee performance, facilitating training programs, and delivering constructive feedback to support professional development.
- Participates in and leads continuous improvement activities utilizing advanced problem-solving techniques and processes, and works collaboratively with R&D, Quality and Production departments to design, develop, test, and implement processes, tooling, fixtures and their associated documentation through change order sign-off.
- Collects data and analyzes process performance and capabilities for company products, including new products and on-market products such as tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
- Leads the development and maintenance of process Failure Modes and Effects Analyses (pFMEAs) for Instrument Systems within the NPI process, collaborates with the Contract Manufacturer for product transfer and continuous improvement, and ensures documentation for design control, product configurations, and other Quality System requirements is developed and maintained.
- Identifies requirements, advises on business cases and justifications, prepares proposals and acquisition plans, and implements equipment and fixturing for development and manufacturing, while also performing productivity and cost analyses to support new product introduction and drive cost reduction for existing products.
The essential requirements of the job include:
- Bachelor s degree in Electrical or Mechanical Engineering with a minimum of 10 years of progressive experience in medical device manufacturing engineering
- Minimum of 3 years of direct management experience in manufacturing operations within the medical device industry
- Demonstrated proficiency with ERP systems such as SAP or Oracle for manufacturing resource planning and supply chain management
- Hands-on experience with manufacturing execution systems (MES), LIMS, or equivalent platforms supporting regulated medical device production environments
- Proven track record of compliance with FDA, ISO 13485, and other applicable regulatory standards in medical device manufacturing
- Documented experience in process validation, equipment qualification, and production line implementation for medical devices
- Available for periodic travel (10-25%) to support manufacturing operations across multiple sites, with valid driver s license and ability to lift up to 25 lbs
It would be a plus if you also possess previous experience in:
- Experience with NPI process, and Design Control process
- Experience of medical regulatory process
- Experience working in a product development environment and/or within manufacturing operations under cGMP, ISO and FDA regulations
