Product Development Engineer

Duties & Responsibilities

• Draft, revise, and maintain product Design History File documentation.
• Draft product verification and validation testing protocols and reports.
• Develop product/process specifications, acceptance criteria, and related sampling plans, as needed.
• Execute testing per approved protocols or test plans.
• Perform first article inspections for new components or supplier materials.
• Generate technical reports to summarize evaluation results.
• Develop and prepare specifications, work instructions, visual aids, and other documentation for manufacturing processes and product testing.
• Troubleshoot product/process issues to determine root cause and develop any necessary corrective and/or preventive actions.
• Aid in the development of product/process risk management documentation.
• Aid with the resolution of manufacturing-related CAPAs and NCRs.
• Support in customer complaint investigations and SCARs, as necessary.
• Develop engineering drawings for inspection gauges, tooling, fixtures, etc.
• Utilize statistical analysis tools to analyze and summarize product and process data.
• Promote an environment of compliance with internal policies and procedures.

Qualifications

• Strong critical thinking and problem-solving abilities.
• Basic understanding of facilities and process utility systems.
• Basic understanding of the use of statistical analysis tools.
• Ability to read and interpret engineering drawings, wiring diagrams, and P&IDs.
• Understanding of OSHA and manufacturing safety.
• Proficient in MS Office suite of products and CAD software (e.g., SolidWorks, AutoCAD, etc.).
• Strong attention to detail and ability to prioritize tasks.
• Able to read and write technical specifications and reports.
• Able to work in teams and interact positively with staff.
• Excellent verbal and written communication skills (including analysis, interpretation, and reasoning).