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

Position

Description

Essential Job Functions

Basic Qualifications

Additional Desirable Qualifications

Skills and Knowledge

Education and/or Experience

• 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.

• Career Summary

  • Coordinates and Supports Suppliers for Manufacturing of Custom Equipment/Tooling
  • Captures and Maintains Documentation for all Equipment/Tooling
  • Captures and Maintains Documentation for all Manufacturing Procedures
  • 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)
  • Generates documentation/justification for assigned capital projects
  • Complies with cGMP’s, Quality Standards , and established policies and procedures
  • Executes other duties assigned by his supervisor

• Technical Writing Skills

  Technical writing skills are required to write SOPs, manufacturing procedures, and reports.

• GMP, ISO, EHS and Statistical Regulations Knowledge

  Knowledge of GMP, ISO, EHS and Statistical regulations is required.

• Strong Computer Skills/Knowledge

  • MS Project knowledge
  • Minitab Proficiency

• Bilingual - English and Spanish (oral and written)

  Bilingual - English and Spanish (oral and written) is required.

• Lean / Six sigma Training/Certification

  Lean / Six sigma Training/Certification is desirable.

• Project Management Training/Certification

  Project Management Training/Certification is desirable.

• Engineering Board Certification (EIT / PE)

  Engineering Board Certification (EIT / PE) is desirable.

• Bachelor’s degree in engineering

  A Bachelor’s degree in engineering is required.

• Experience in the Medical Device / Pharmaceutical Industries

  Experience in the Medical Device / Pharmaceutical Industries is required.

• Experience in the following fields:

  • Manufacturing
  • New Product Transfers
  • Product / Process Development

• Qualification / Validation (IQ/OQ/PQ)

  Experience in Qualification / Validation (IQ/OQ/PQ) is desirable.

• Test Method Validation / Gage R&R

  Experience in Test Method Validation / Gage R&R is desirable.

• Process Characterization / Design of Experiments (DOE)

  Experience in Process Characterization / Design of Experiments (DOE) is desirable.

• Manufacturing Line Design / Capacity Analysis

  Experience in Manufacturing Line Design / Capacity Analysis is desirable.

• Equipment / Tooling Design

  Experience in Equipment / Tooling Design is desirable.

• Equipment Installation / Preventive Maintenance Procedure Generation

  Experience in Equipment Installation / Preventive Maintenance Procedure Generation is desirable.

• Root Cause Analysis / Investigation

  Experience in Root Cause Analysis / Investigation is desirable.

• SOP / Manufacturing Procedures Generation & Change Control

  Experience in SOP / Manufacturing Procedures Generation & Change Control is desirable.

• Product Financials & Supply Chain Structure Design

  Experience in Product Financials & Supply Chain Structure Design is desirable.

• OEE Integration, Vertical Start up and Zero-loss mindset

  Experience in OEE Integration, Vertical Start up and Zero-loss mindset is desirable.