- Contribute to continuous improvements in overall product cost and quality.
- Participate in DFM / DFA activities assuring that packaging/production processes and equipment are taken into consideration.
- Maintain documentation associated with packaging/manufacturing processes.
- Provide technical support for production packaging/labeling tools and software including assembly/sealing equipment and automation.
- Follow established guidelines and management direction with regard to engineering decisions.
- Advise leadership of developments which may affect schedule and costs.
- Participate on projects to concurrently develop packaging assembly methods, tooling, equipment and processes for new and existing products.
- Partner with Manufacturing to develop lean principals to implement solutions for product packaging, labeling and sealing/assembly.
- Create standardized work and process maps that result in an optimized production system and extended value stream.
- Conduct, coordinate and aid in formal Process Validations including protocol development and execution.
- Support line validation / qualification activities for including IQ, OQ, MSA and PQ.
- Support project team members in achieving business objects related attainment of Safety, Quality, Service, and Project Schedule and Cost goals.
- Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.
- Interactions with manufacturing providing hands-on support and responsibility for metrics such as labor time, lead-time, capability, and yield.
- Provide detailed engineering analysis and documentation in the management of material disposition, process updates, Client's and CAPA.
- Perform root Cause Analysis (RCA), Client and CAPA responses.
- Complete on time project updates, development plans, self-assessments, and successful completion of all training requirements.
- Application of statistical and analytical methods such as SPC, SQC and DOE.
- Contributor to the Capital Expense Request (CER) process, specify cost for packaging/labeling/sealing equipment with consideration to product standard cost targets and capacity demands.
- Strong leadership skills and able to take direction
- Knowledge of Lean and/or 6 Sigma
- Knowledge of GD&T
- Knowledge of DFMEA and PFME
- Strong Interpersonal Skills
- Strong Computer Skills
- Strong Project Skills
- Knowledge and Experience with packaging, assembly and manufacturing methods/equipment (i.e.: Sencorp bar sealers, Alloyd blister sealers and material sealing of PETG to tyvek, foil to tyvek, foil to foil, mylar to Tyvek) and Vision Systems.
- Knowledge and Experience with packaging material process and testing.
- Engineering and Problem-solving tools: MINITAB, SIX SIGMA, DOE, GR&R, CAPA, CAD, DMAIC
- Experience with DFMA and Lean manufacturing tools.
- Excellent organization, Planning, Computer skills, technical writing, Communication and Presentation skills.
- B.E - Mechanical Engineering/Industrial Engineering .
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Quality Engineer - Princeton, United States - Diverse Lynx
Description
Role: Quality EngineerLocation: Plymouth, MN
Onsite from Day 1
Client: L&T/Healthcares
Rate: 48/hr on C2C maximum
Look for Medical devices background. No OPTs
This is a new customer and we want to build this so do not COMPROMISE when it comes to the quality. Only best profiles please.
Job Description: