Posted on Dec 31, 2017 by Administrator
As a Senior Manufacturing Process Engineer, each day will offer new challenges as you tackle a variety of responsibilities, including Oversight of 4 existing engineers and 15 Contract employees. Managing all aspects of different projects and overseeing the machine operations, resolving issues on machines. Experience with FDA documentation, validations, VFDA, QSR.
- Take ownership of project success for new and existing families of production.
- Coordinate cross-functional teams to execute and document the manufacturing launch of new/legacy products.
- Determine manufacturing processes required to accurately and efficiently make spinal implants, from raw material to final cleaning and shipment.
- Interface with Quality Engineering to determine critical manufacturing process and control characteristics.
- Develop and complete manufacturing documentation (pFMEA, control plan, process flow, work instructions, and inspection plans).
- Perform research, design, and development of manufacturing processes including production flow, assembly methods, and production equipment.
- Execute the Engineering Change Process for process updates and improvements.
- Perform product/process analysis and troubleshooting for cost reduction, quality improvement, and improved efficiency.
- Design, develop, test, source, and cost-justify various tools, machinery, and equipment for recommended manufacturing methods.
- Coordinate and manage the estimating/quoting process.
- Lead design for manufacturability analysis with CNC Programmers and Quality Engineers, and provide input to Development (Design) Engineers.
- Support process validation by working with validation engineers to clarify methods, inputs, and outputs of processes or equipment.
- Implement, maintain, analyze and react to various production data logs.
- Participate in NCMR Process in containment, root cause analysis, and implementation of permanent corrective actions.
- 5-10 years experience
- Must have managed projects – to include financials and timelines
- Proficient with Microsoft office
- Proven ability and fluency in Print Reading and GD&T, Statistical Process Control, Lean Manufacturing, Six Sigma
- Experience in 21 CFR 820 and/or ISO 13485 regulated environment
- Experience in a CNC manufacturing environment is preferred.
- Bachelor’s degree (BS); in a technical engineering discipline.
For confidential consideration please send details to:
Director of Technical Recruitment
TriStaff Group | San Diego, CA 92122