Product Development Engineer: Process & Validation

HR HealthCare; York (York County); On-site; USD 65,000 - 92,000; Full time

Job summary

HR HealthCare seeks a Product Development Engineer to support engineering and validation activities, from evaluating sourced materials to finished goods manufacturing. This role ensures compliance and improves production efficiency.

The position supports product development, process and supplier qualifications, and continuous improvement projects to enable compliant manufacturing and timely product introductions.

Qualifications

• Bachelor's degree in engineering or related field.
• 1–3 years of product development or manufacturing experience.
• Ability to read and interpret engineering drawings and diagrams.
• Familiarity with statistical analysis and quality systems.

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 sampling plans.
• 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 engineering drawings for inspection gauges, tooling, fixtures, etc.
• Troubleshoot product/process issues to determine root cause and corrective actions.
• Assist in CAPA and NCR resolution and risk management documentation.
• Support customer complaint investigations and SCARs as needed.

Skills

Critical thinking

Problem solving

Reading engineering drawings

Statistical analysis

Team collaboration

Verbal and written communication

MS Office

Education

Bachelor's degree in engineering (mechanical or biomedical preferred)

Tools

SolidWorks

AutoCAD

Job description

HR HealthCare seeks a Product Development Engineer to support engineering and validation activities, from evaluating sourced materials to finished goods manufacturing. This role ensures compliance and improves production efficiency.

The position supports product development, process and supplier qualifications, and continuous improvement projects to enable compliant manufacturing and timely product introductions.