Sr. Product Development Engineer

BD Biosciences

Job Description SummaryLeads 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. Job Description

  • Coordinates purchase and delivery of Equipment/Tooling
  • Coordinates installation of Equipment/Tooling
  • Develops and Executes Usage Requirements Specifications and Factory Acceptance Tests
  • 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
  • Designs / Coordinates Facilities Modifications
  • Develops Manufacturing Capacity Analysis
  • Develops and Maintains Project Timeline / Plan
  • 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:

  • Strong Technical writing skills
  • Strong Computer Skills/Knowledge (Word, Excel, PowerPoint)
  • MS Project knowledge
  • Experience in the Medical Device / Pharmaceutical Industries: Yes
  • 5+ years of experience in the following areas of the Medical device or pharmaceutical industries:
  • Manufacturing
  • Qualification / Validation (IQ/OQ/PQ)
  • Packaging Validation
  • Manufacturing Line Design / Capacity Analysis
  • Equipment / Tooling Design
  • Root Cause Analysis / Investigation
  • Product Financials & Supply Chain Structure Design

Additional Desirable Qualifications Skills and Knowledge:

  • Engineering Post Graduate Degree (Masters / PhD)
  • Lean / Six sigma Training/Certification

Physical Demands:

Work Environment:

  • Hours of operation are flexible and vary depending on job requirements.  Typical work week is 40 hours with additional/variable hours for specific work periods and projects.  Specific work days and hours are flexible and may change with advance notice
  • The nature of the work requires occasional exposure to chemicals, noise, as well as occasional exposure to machinery and non-ionizing radiation.

Training Requirements:

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Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

More Information

Type

Executive / senior industry position

North%20America%2C%20San%20Jose%2C%20United%20States

North America

San Jose , United States

Location

United States

San Jose

Type

Executive / senior industry position

North%20America%2C%20San%20Jose%2C%20United%20States