Process Engineer

Position Overview

Viltis is seeking a Process Engineer to support a critical Design History File (DHF) remediation initiative within a regulated medical device manufacturing environment. This role will lead cross‑functional project activities focused on design controls, process validation, risk management, and technical documentation.

The ideal candidate will have experience in regulated industries, strong technical writing capabilities, and the ability to collaborate effectively across engineering, quality, manufacturing, and operations teams.

• Lead and coordinate weekly project activities, deliverables, and status updates.
• Collaborate with cross‑functional teams to ensure project milestones are achieved.
• Support on‑site process validation efforts and equipment installation activities.
• Drive execution of remediation activities while maintaining alignment with program timelines.

• Author, review, and maintain Design History File (DHF) documentation.
• Serve as Process Validation Owner for:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Develop and maintain risk management documentation, including Process Failure Mode and Effects Analysis (pFMEA).
• Support design transfer activities and documentation.

• Apply statistical analysis methods to support engineering decisions.
• Design and execute Design of Experiments (DOE).
• Support Test Method Validation (TMV) activities.
• Ensure documentation complies with applicable quality and regulatory requirements.

Experience in one or more of the following areas is beneficial but not required:

• Formulations and mixing dynamics
• Tank and vessel design
• Process scale‑up activities

• Capping and labeling equipment
• Packaging assembly processes

• pH measurement systems
• Viscometers
• Moisture analyzers

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum of 2 years of experience in a regulated industry utilizing design controls.
• Experience with technical documentation and validation activities.
• Strong written and verbal communication skills.
• Proficiency with Microsoft Office applications.

• Experience in medical device manufacturing.
• Familiarity with quality management systems such as ISO 9001 and ISO 13485.
• Experience supporting DHF remediation, process validation, or product development programs.

Performance in this role will be measured by:

• Completion of accurate, compliant, and thorough technical documentation.
• Successful execution of assigned validation and engineering activities.
• Consistent reliability, attendance, and adherence to safety requirements.
• Ability to support project timelines without unnecessary rework or delays.

• Safe and compliant working environment.
• Required equipment, tools, and PPE.
• Access to applicable procedures, systems, and training.
• Collaboration with experienced engineering, quality, and manufacturing professionals.
• Opportunity to contribute to impactful medical device development and remediation initiatives.