Medical Device Process Engineer — Lean & Validation

Angel Aligner; Oak Creek (WI); On-site; USD 85,000 - 110,000; Full time

Job summary

Angel Aligner is seeking a Process Engineer to design, implement, and optimize manufacturing processes for medical devices, ensuring product quality and regulatory compliance across the plant. The role collaborates with design, quality, and regulatory teams to validate processes, troubleshoot issues, and support continuous improvement through data-driven analysis and CAPA programs.

Responsibilities include developing equipment layouts, leading validation activities, ensuring safety standards,

Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related engineering field is required.
• Experience in a regulated manufacturing environment is preferred for medical devices.
• Knowledge of FDA 21 CFR Part 820, ISO 13485, and GMP requirements is expected.
• Strong analytical, problem‑solving, and statistical skills are essential.
• Proficiency with CAD, statistical software, and process‑mapping tools is required.
• Ability to conduct risk assessments and validation activities.

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 consistent output quality.
• Supports CAPA and root‑cause investigations.
• Collaborates with quality engineers to ensure product consistency and adherence to acceptance criteria.
• Works with R&D to transfer new products into manufacturing.

Skills

Analytical thinking

Problem solving

Statistical analysis

Education

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

Tools

CAD

Process mapping tools

Statistical software

Job description

Angel Aligner is seeking a Process Engineer to design, implement, and optimize manufacturing processes for medical devices, ensuring product quality and regulatory compliance across the plant. The role collaborates with design, quality, and regulatory teams to validate processes, troubleshoot issues, and support continuous improvement through data-driven analysis and CAPA programs.

Responsibilities include developing equipment layouts, leading validation activities, ensuring safety standards,