Product Development Engineer - Urgent Need
MillenniumSoft Inc, El Paso, TX, United States
Location: El Paso, TX | Duration: 12 Months | Total Hours/week: 40 | 1st Shift | Client: Medical Devices Company | Job Category: Engineering | Employment Type: Contract on W2 (Need US Citizens or GC Holders or GC EAD or OPT or EAD or CPT)
Position
Product Development Engineer - Urgent Need
Summary of Position
Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.
Essential Job Functions
Coordinates and supports suppliers for manufacturing of custom equipment/tooling
Coordinates purchase and delivery of equipment/tooling
Coordinates installation of equipment/tooling
Develops and executes IQ and OQ protocols and reports
Develops and executes test method validations / Gage R&R
Generates and issues SOPs and manufacturing procedures for approval
Develops and executes component qualifications
Develops and executes PQ and PPQ protocols and reports
Develops manufacturing capacity analysis
Develops and executes process characterizations / design of experiments (DOE)
Develops documentation/justification for assigned capital projects
Complies with cGMPs, quality standards, and established policies and procedures
Executes other duties assigned by supervisor
Basic Qualifications
Bilingual – English and Spanish (oral and written)
Technical writing skills
Knowledge of GMP, ISO, EHS, and statistical regulations
Strong computer skills/knowledge (Word, Excel, PowerPoint)
MS Project knowledge
Minitab proficiency
Additional Desirable Qualifications, Skills, and Knowledge
Lean / Six Sigma training / certification
Project management training / certification
Engineering board certification (EIT / PE)
Education And/Or Experience
Bachelor’s degree in engineering
Experience in the medical device / pharmaceutical industries: Yes
Experience Requirements (5+ years)
Manufacturing
New product transfers
Product / process development
Job Functions Experience In The Following
Qualification / validation (IQ/OQ/PQ)
Test method validation / Gage R&R
Process characterization / design of experiments (DOE)
Manufacturing line design / capacity analysis
Equipment / tooling design
Equipment installation / preventive maintenance procedure generation
Root cause analysis / investigation
SOP / manufacturing procedures generation & change control
Product financials & supply chain structure design
OEE integration, vertical start up and zero-loss mindset
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Position
Product Development Engineer - Urgent Need
Summary of Position
Leads the technical support to new product transfers and/or product development projects. Possesses technical responsibility for interpreting, planning, organizing, executing, coordinating, and carrying out technical assignments based on diversified requirements.
Essential Job Functions
Coordinates and supports suppliers for manufacturing of custom equipment/tooling
Coordinates purchase and delivery of equipment/tooling
Coordinates installation of equipment/tooling
Develops and executes IQ and OQ protocols and reports
Develops and executes test method validations / Gage R&R
Generates and issues SOPs and manufacturing procedures for approval
Develops and executes component qualifications
Develops and executes PQ and PPQ protocols and reports
Develops manufacturing capacity analysis
Develops and executes process characterizations / design of experiments (DOE)
Develops documentation/justification for assigned capital projects
Complies with cGMPs, quality standards, and established policies and procedures
Executes other duties assigned by supervisor
Basic Qualifications
Bilingual – English and Spanish (oral and written)
Technical writing skills
Knowledge of GMP, ISO, EHS, and statistical regulations
Strong computer skills/knowledge (Word, Excel, PowerPoint)
MS Project knowledge
Minitab proficiency
Additional Desirable Qualifications, Skills, and Knowledge
Lean / Six Sigma training / certification
Project management training / certification
Engineering board certification (EIT / PE)
Education And/Or Experience
Bachelor’s degree in engineering
Experience in the medical device / pharmaceutical industries: Yes
Experience Requirements (5+ years)
Manufacturing
New product transfers
Product / process development
Job Functions Experience In The Following
Qualification / validation (IQ/OQ/PQ)
Test method validation / Gage R&R
Process characterization / design of experiments (DOE)
Manufacturing line design / capacity analysis
Equipment / tooling design
Equipment installation / preventive maintenance procedure generation
Root cause analysis / investigation
SOP / manufacturing procedures generation & change control
Product financials & supply chain structure design
OEE integration, vertical start up and zero-loss mindset
#J-18808-Ljbffr