Product Development Engineer - Min 4-5 Yrs Exp is Req in medical device & Pharmacetuical Industry

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

Benefits offered by this job

None

Job summary

MillenniumSoft Inc in El Paso, TX seeks a Product Development Engineer for a 12-month contract. The role leads technical support for new product transfers and development projects, with responsibility for interpreting, planning, coordinating, and executing technical assignments.

Qualifications include bilingual English/Spanish, strong technical writing, GMP/ISO/EHS knowledge, proficient with Word, Excel, PowerPoint, MS Project, and Minitab; a bachelor's degree in engineering and 5+ years in

Qualifications

• Bachelor’s degree in engineering is required.
• Bilingual ability in English and Spanish (oral and written).
• Experience with GMP, ISO, EHS regulations expected.
• Proficient with MS Word, Excel, and PowerPoint; MS Project familiarity.
• Familiarity with Minitab for statistical analysis is preferred.

Responsibilities

• Leads technical support for new product transfers and development projects.
• Interprets, plans, organizes, and executes technical assignments.
• Coordinates and supports equipment/tooling manufacturing and installation.
• Develops IQ/OQ/PQ protocols, tests, and manufacturing documentation.
• Ensures compliance with quality policies and procedures.

Skills

Bilingual English/Spanish

Technical writing

GMP/ISO/EHS knowledge

MS Office

MS Project

Minitab

Education

Bachelor’s degree in engineering

Tools

MS Project

Minitab

Job description

Job Category : Engineering

• 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

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