Project Process Engineer - Medical Devices (5-8 yrs)
The Engineer will be based in Bawal and will serve Manufacturing Operations as the primary customer. The position will liaise with Global Engineering (GE), Core Business Initiatives, Quality Assurance (QA), Continuous Improvement (CI) & Supply Chain (SCM) in order to effectively carry out its responsibilities.
This person will lead and coordinate the Process / Manufacturing Engineering activities associated with maximizing efficiency and effectiveness and developing existing manufacturing capacity. OEE and waste optomization, process improvement and reliability excellence of medium to high automation assets are key elements of this role. The role will include leading manufacturing / Process Engineers (Subject Matter Experts) for diverse technologies.
- Process Improvements: Position will be responsible for identifying and implementing process & product improvements in the area including Overall Equipment Effectiveness (OEE), yield and process up-time. As an Engineer, contribute to process improvement targets and planning to meet strategic business goals (5-year outlook) and related annual budget.
- Use data analytics software and SPC techniques to optimize performance.
- Facilitate Total Productive Manufacturing programs for assigned assets as a key enabler (Training will be provided). Support spares and consumables budget, preventive maintenance and calibration schedules.
- Responsible for the provision of high-level technical support and response to Operations requirements. Support first line responders / Craftspersons and Production Associates.
- Support operation enablers such as Total Productive Maintenance Program, Standard Work, Visual Management and other Lean Sigma initiatives.
- Process Qualification: Periodic support qualification of new products / processes, and ensure compliance to quality standards through execution of protocols.
- New Product introduction: support timely introduction on any new products or product upgrades in the designated Value Stream area; including development of product costs (COGS).
- Safety/ Risk Assessments: responsible for ensuring safety compliance in the area and supporting both execution and timely closeout of risk assessments
- Project Planning & Tracking: responsible for reporting on process performance, plans to optomize the process and project management where applicable. Formally communicating / reporting same. Responsible for maintaining project budgetary control.
- Mentor and actively support and coach Process / Manufacturing fitters in order to develop their technical and professional capabilities.
- Work closely with frontline resources such as the Operational Shift Team Leader, Fitters, Production Associates and other relevant support functions.
- Flexibility / periodic out-of-office hours support is critical in support of Operations requirements at short notice. Operations run 24-7 / 48 weeks of the year.
SKILLS & QUALIFICATIONS :
- Primary Degree in Engineering discipline, preferably Mechanical, or Manufacturing Engineering
- Masters in Project Management or Manufacturing Systems or equivalent
2. Specialized or Technical Knowledge
- Medium to high volume automation experience pneumatics, pick and place, vision systems, robotics and ideally including PLC/Controls
- Continuous improvement tools and techniques to measure and improve the process.
- Familiarity with validation and DOE techniques, statistical analysis tools, and/or DFM principles.
- Foundation knowledge of Lean Sigma principles
- Excellent root cause analysis skills - Data Analytics / SPC Capability
- ASQ Green/Black Belt Certification / Lean Manufacturing experience
- Machine design experience
- PLC / Software experience
- Project Management Training/Qualification
- Supervisory or commercial experience
- Reliability Excellence Experience (Total Productive Maintenance, Autonomous Maintenance, Reliability / Predictive Maintenance)
3. Kind and Length of Experience:
- 5+ years post qualification experience in general Manufacturing Engineering, with a focus on mechanical systems & their application in a manufacturing environment (batch type process for the medical devices / healthcare / pharmaceutical/ industry preferred)
- 3yrs+ Process Optimization and development experience.
- People management experience and budgetary responsibilities.
- Flexibility in support of a 24-7 operation. - FDA, ISO13485 or equivalent experience preferred
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