This process engineering position supports the design engineering team during the development phases with manufacturing process expertise and early stage input in product development. As the product goes through from concept to production, this role will help transfer the design from specifications onto the manufacturing floor. This position conducts engineering activities in support of manufacturing operations, which may include: process improvements, component and material changes, implementation of product design changes, Value Analysis / Value Engineering (VAVE), process validation (IQ, OQ, PQ), and manufacturing process transfer activities.
- Capable working collaboratively contributing on a cross-functional team
- Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
- Design of Experiments (DOE) Process characterization and analysis experience
- Expertise to incorporate inspection and test requirements into the production plan.
- Expertise in CNC machining, additive processes, or equivalent process methods.
- Adapts machine or equipment design to factory and production conditions.
- Six Sigma Lean and or DMAIC, DRM or equivalent Black Belt preferred
- Expertise developing processes with high levels of capability.
- Expert in Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
- Software tools: MS Excel, Word, Power Point Project, Minitab, JMP or equivalent,
- Develops and executes Process Qualification methods: IQ, OQ, PQ, pFMEA, MSA, TMV
- Develops processes with high yielding product and ability to solve complex challenges.
- Be an expert (SME) in design of manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
- Office proficient, experience with PDM/PLM systems, Priority
- Ability to set work direction, work independently, and communicate with a vast network of global stakeholders.
- Advanced knowledge of job area with all applicable industry standards (ISO, ASTM, SAE, AMS, ANSI)
- Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD – Significant advantage
“Hands on”, Independendent, quick learner and a team player.
- Six Sigma (DRM-DFSS) Green/Black Belt skills and experience – Advantage
- Excellent communication skills, both verbal and written in English
Qualification & Experience:
- Experience with design of surgical tools – Significant advantage
- 3 years minimum Process Engineering and / or Process Development Experience, preferred in a medical device manufacturing industry
- Experience in Medical Device companies – Significant advantage
- 4+ years of experience with Bachelors Degree OR 2+ years of experience with an Advanced Degree
- Bachelor’s degree
Vacancy Type: Full Time
Job Functions: Information Technology
Job Location: Memphis, TN, US
Application Deadline: N/A