Process Engineer

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

Job Summary:

A Process Engineer in the medical device sector designs, implements, and improves manufacturing processes to ensure product quality, regulatory compliance, and operational efficiency. They collaborate with cross‑functional teams—including design, quality, and regulatory—to validate processes, troubleshoot issues, and support continuous improvement.

Essential Functions:

• 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, consistent with process engineer roles that involve analyzing and upgrading processes


• 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.


• Ensures processes comply with safety, environmental, and regulatory standards, reflecting the need to meet compliance regulations in process engineering


• Prepares and maintains validation protocols, reports, and risk assessments.


• Monitors production processes and resolves technical issues to maintain consistent output quality.


• Supports root‑cause investigations and corrective/preventive actions (CAPA).


• Collaborates with quality engineers to ensure product consistency and adherence to acceptance criteria.


• Works with R&D to transfer new products into manufacturing.


• Partners with quality, regulatory, and supply chain teams to ensure smooth production and audit readiness.


• Supports documentation updates, including work instructions, SOPs, and process specifications.


• Analyzes process performance metrics and identify improvement opportunities.


• Prepares technical reports and present findings to engineering and leadership teams.

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


• .Strong analytical, problem‑solving, and statistical skills


• .Proficiency with CAD, statistical software, and process‑mapping tools


• .Ability to conduct risk assessments and validation activities

Preferred but not required Qualification

• s:Experience with automation, robotics, or advanced manufacturing technologie


• s.Six Sigma Green Belt or Black Belt certificatio


• n.Experience with cleanroom manufacturing or sterile device processe


• s.Familiarity with Design for Manufacturability (DFM) and Design Transfe

r

• s:Strong problem‑solving and critical‑thinking skil


• lsHigh attention to detail and documentation accuracyAbility to work cross‑functionally in a fast‑paced environme


• ntCommitment to patient safety and product quali

e

t Physical and Work Environment Requirement

• s:Ability to work in office, lab, and manufacturing environmen


• tsOccasional travel for supplier audits or traini


• ngAbility to lift up to 40 l

b

• tsTravel is approximately 5% with international overnight stays requir


• edWe offer a competitive base salary and benefit