Product Development Engineer

Summary of Position

The Product Development Engineer will be responsible for assisting the engineering and validation team with product development and manufacturing responsibilities to ensure compliance and improve production efficiency. This individual will support product development and manufacturing, from evaluating sourced materials, components, and products through to the manufacture of finished goods. The Product Development Engineer will assist with activities related to process and supplier qualifications, continuous improvement projects, and product development to ensure compliance.

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.
• Assist in the development of product/process risk management documentation.
• Assist 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.
• Other duties, as assigned.

Qualities

• 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)

Qualifications

• Bachelor’s degree program in engineering or a related field; mechanical or biomedical engineering preferred
• 1-3 years of product development and/or manufacturing-related experience or equivalent, particularly in an engineering or technical role