Process Engineer - Medical Devices & Validation

Valid8 Financial, Inc.; Oak Creek (WI); On-site; USD 85,000 - 125,000; Full time

Job summary

Valid8 Financial, Inc. is seeking a Process Engineer to design, implement, and optimize manufacturing processes for medical devices, ensuring quality, regulatory compliance, and operational efficiency.

The role collaborates with design, quality, and regulatory teams to validate processes, troubleshoot issues, and drive continuous improvement across production, validation, and documentation activities.

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related engineering field.
• Experience in a regulated manufacturing environment (medical device preferred).
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements.

Responsibilities

• Designs, develops, and optimizes manufacturing processes for new and existing medical devices.
• Conducts experiments and analyzes data to improve efficiency, reduce cost, and enhance product quality.
• Develops equipment layouts and process flow diagrams.
• Implements lean manufacturing and continuous improvement initiatives.
• Leads IQ/OQ/PQ validation activities to ensure processes meet FDA and ISO 13485 requirements.
• Prepares and maintains validation protocols, reports, and risk assessments.
• Monitors production processes and resolves technical issues to maintain output quality.
• Supports CAPA and root-cause investigations.
• Collaborates with quality engineers to ensure product consistency and acceptance criteria.
• Works with R&D to transfer new products into manufacturing.
• Partners with quality, regulatory, and supply chain teams for audit readiness.
• Supports documentation updates, including work instructions, SOPs, and process specifications.
• Analyzes process performance metrics and identifies improvement opportunities.

Skills

Analytical skills

Problem-solving

Statistical skills

CAD

Process mapping

Validation activities

Cross-functional collaboration

Education

Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related engineering field

Tools

CAD

Statistical software

Process mapping tools

Job description

Valid8 Financial, Inc. is seeking a Process Engineer to design, implement, and optimize manufacturing processes for medical devices, ensuring quality, regulatory compliance, and operational efficiency.

The role collaborates with design, quality, and regulatory teams to validate processes, troubleshoot issues, and drive continuous improvement across production, validation, and documentation activities.