The Manufacturing Engineer will work with continuous improvement initiatives and be responsible for overall equipment performance and executing equipment validations, including efficiency tracking and problem solving. The manufacturing process consists of reagent mixing, cartridge assembly, filling and welding processes and packing process of finished goods. The processes are both manual and semi-automated and quality requirements are high. The role will require hands on engagement at the tool, troubleshooting mechanical, electro-mechanical, electrical and automation controls and implementing solutions. The role will require close interaction with the global “Make in India” project team as this is a greenfield project with the aim of establishing local manufacturing in India with most equipment being built and shipped from the US. This person will be the technical partner to the engineering/ manufacturing team in USA/Sweden/India throughout the life cycle of the equipment.
ESSENTIAL JOB RESPONSIBILITIES:
- Lead equipment installations and process validations for assembly lines and packing lines in compliance with company standards, IVD regulations and GMP standards
- Suggest, initiate and execute continuous improvement projects for manufacturing equipment and processes
- Collaborate with manufacturing team, management and associates, to support the manufacturing processes and understand improvement opportunities
- Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve line performance issues
- Partner effectively during root cause investigation through resolution with functional and global representatives of regulatory, automation, molding/tooling, production and quality.
- Compile and evaluate test data to determine appropriate limits and variables for process or material specifications.
- Handling of CAPAs, change orders and validation processes
- Complete Engineering Change Orders (ECO) to Work Instructions, Tool (IOPQ) Protocols, Drawings and BOM lists and participate in global projects for tool upgrades, problem solving and KAIZENs
- Execute documentation as per QMS requirements, including preparation of validation protocols or change orders to fulfill documentation requirements
Complete all assigned and required training satisfactorily and on time
For people managers, ensure your associates attend and complete all required trainings satisfactorily and on time.
Educate and train peers and associates in equipment processes, instructions or quality requirements, upgrades or changes
Responsible for driving assemblers’ engagement and for developing Lean and Six Sigma capabilities through coaching and mentoring.
Education and Experience (in years):
Knowledge and skills:
- BE/ B Tech/ M Tech/Automation/ Engineering or MSc from an Indian recognized university having 3+ years of experience from manufacturing in engineering function
- Excellent communication, written and oral presentation skills (English)
- Experience from working with automated processes
- Strong analytical and problem-solving skills combined with a strong technical understanding
- Good Understanding of mechanical design concepts and machinery: Electrical, Mechanical, and Electromechanical schematics, motors, pumps, vacuum, and hydraulics
- Proven experience of leading and delivering improvement results to set targets and timelines
- Knowledge and experience working with PLC and Control Systems
- Knowledge and experience working with of working with robotics
- Experience from working in a regulated work environment (ISO, GMP and Medical Device 9001,14001,13485)
- Ability to successfully interact with cross-functional teams
- Experience from working in a global environment
- Ability to work in manufacturing environment
- Must be flexible to work off-shifts and weekends if required at call-in.
- Having a valid Indian Passport
- Experience from Medical Device manufacturing for US & CE markets
- Lean Manufacturing knowledge
- Agile Product Lifecycle Management (PLM)
- Experience from reagent processes