Product Development Engineer - Urgent Need

MillenniumSoft Inc; El Paso (TX); On-site; USD 34,000 - 41,000; Full time

Job summary

MillenniumSoft Inc in El Paso, TX is urgently seeking a Product Development Engineer for a 12‑month, 40‑hour/week contract (W2). The position offers a first shift, a pay range of $25-$30 per hour, and requires US work authorization.

You will lead technical support for new product transfers and development projects, coordinate IQ/OQ/validation activities, support manufacturing tooling and QA processes, and ensure compliance with GMP/ISO/EHS standards.

Qualifications

• Bilingual in English and Spanish (oral and written).
• Technical writing skills for SOPs and reports.
• GMP, ISO, EHS and statistical regulation knowledge.
• Strong computer skills (Word, Excel, PowerPoint).
• MS Project knowledge.
• Minitab proficiency.

Responsibilities

• Coordinates and supports manufacturing of equipment/tooling.
• Coordinates purchase, delivery, and 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.
• Performs component qualifications; PQ/PPQ protocols and reports.

Skills

Bilingual (English and Spanish)

Technical writing

GMP/ISO/EHS knowledge

Strong computer skills (Word, Excel, P

Education

Bachelor’s degree in engineering

Tools

MS Project

Minitab

Job description

Location : El Paso, TX

Duration : 12 Months

Total Hours/week : 40.00

pay range -$25-30/hr

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

• Summary of Position with General Responsibilities:


• 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.

Position : Product Development Engineer - Urgent Need

Location : El Paso, TX

Duration : 12 Months

Total Hours/week : 40.00

pay range -$25-30/hr

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

Job Description

• Summary of Position with General Responsibilities:


• 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 for Approval SOPs and Manufacturing Procedures


• 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 cGMP’s, Quality Standards , and established policies and procedures


• Executes other duties assigned by his supervisor

Basic Qualifications

• Bilingual (English and Spanish (oral and written))


• Technical writing skills


• GMP, ISO, EHS and Statistical regulations knowledge


• 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

5+ years of experience in the following fields:

• 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