Job Summary
The Lead NPI Product Engineer is responsible for leading a team of engineers in prototyping, debugging and executing engineering efforts as assigned by the Business Unit, PMO, or Design Engineering Manager.
The Lead NPI Product Engineer will focus on the manufacturing of several products at the Design Verification Stage (DVT). There are notable complexities in both the manufacturing and test processes due to the product densities, combination of mechanicals, electronics and fluidics, plus the functionality complexities of the chemistries and functional processes encountered in start-up and operation.
The manufacturing environment would start in a restricted lab for the assembly of these units and tight controls must be kept in place to help maintain overall product and materials traceability and configuration control. The Lead NPI Product Engineer role is to facilitate transfer of products in a controlled and planned methodology from design to manufacturing facility.
Essential Duties And Responsibilities
1. Works with Design Team and Customer to meet build requirements.
2. Works with Engineering team to layout and commission the manufacturing work area and materials storage to meet requirements.
3. Works with team to define and solution traceability requirements and configuration management.
4. Works with production transfer Engineer/s to learn and prepare for DVT/PVT builds by documenting change requirements and future actions to aid in the transfer.
5. Supports trouble-shooting activities and data/knowledge collection/management activities with Test.
6. Ensures that Visual Aids are complete and adhered to. Updates for improvements are made based on manufacturing flow, inspection requirements and yield results.
7.
Support the assessment of resource loading and task assignment to accomplish the job to schedule.
8. Contribute to the cost management effort by supporting forecast review and visibility to changes in budget.
9. Use the RACI to help drive accountability.
10. Support the transfer of manufacturing to the production site through an extended launch schedule to ensure sustainability.
11. Identify creative ways to reduce cost by streamlining processes and systems.
12. Utilize tools to monitor departmental cost and cost trends, striving continuously to improve value.
13. Provide feedback to peers on cost and cost trends.
14. Demonstrate a commitment to customer service; anticipate, meet and exceed expectations by solving problems quickly and effectively.
15. Establish new measurement systems if/where possible.
16.
Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
17. Interpret a variety of instructions furnished in written, oral, diagram or schedule form.
18. Work concurrently with Jabil CAD Services, Design Engineering, Business Unit Management, Manufacturing, Test, Purchasing, and Quality departments through the design phase of a program.
19. Work to provide a design that not only meets the customer's criteria, but is also of high quality, cost effective, and manufacturability.
20. Provide Business Unit Management / Business Development/PM's/Functional Mgt. with timely and accurate VAVE quotations to aid in the quoting process.
21. Oversee the defining of procedures and practices to determine appropriate action.
22.
Provide support to the Engineering Services Department through participation in the continuous improvement effort and promotion of a "Quality First" attitude.
23. Present capabilities and results to both internal and external customers.
Management & Supervisory Responsibilities
1. Typically reports to Management. Direct supervisor job title(s) typically include: Engineering Manager.
2. Job is not directly responsible for managing other employees (e.g., hiring/termination and/or pay decisions, performance management).
Job Qualifications
KNOWLEDGE REQUIREMENTS
1. Prototype and NPI skillsets in complex electromechanical and fluidics systems.
2. Production sustaining and IE optimization of manufacturing lines.
3. Extensive experience working with NPI release documentation in need of redlines, updates, spec review and change control.
4. High level of cGMP in ISO13485 environment, safe working practices and awareness.
5.
Familiar with plastic joining techniques – laser, USW, chemical bonding.
6. Familiar with incoming materials and receiving inspection.
7. Program management visibility to manufacturing readiness and clean to start requirements.
8. Experience in production transfer and readiness.
9. Experience with operator training programs and development of robust visual aid.
10. Lean Six sigma training. Quality first mentality and development of robust inspection strategies.
11. IQ, OQ, PQ protocols, testing, Gage R, validations, rationales.
12. Development of trouble-shooting guides for manufacturing operations.
13. Budget forecasting management.
14. Proven track record of successful change management accomplishments, implementing and management continuous productivity and cost reduction programs.
15. Proficiency in use of personal computers,
Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required. Microsoft project and complex task resource scheduling. CAD, Windchill and SAP experience preferred.
Education & Experience Requirements
1. Bachelor's Degree required.
2. Degree in Electrical, Industrial or Mechanical Engineering discipline.
3. Minimum of 8-10 years work-related experience required, preferably in an NPI Manufacturing, engineering environment.
4. Experience with hemodialysis or fluidics-based equipment manufacturing, testing and trouble-shooting preferred.
5. Or a combination of education, experience and/or training.
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