Process Engineering Positions

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.

Serve as Process Validation Owner for:
Installation Qualification (IQ)

Performance Qualification (PQ)

Develop and maintain risk management documentation, including Process Failure Mode and Effects Analysis (pFMEA).

Process Engineering & Validation

Apply statistical analysis methods to support engineering decisions.

Ensure documentation complies with applicable quality and regulatory requirements.

Filling & Packaging Operations

Capping and labeling equipment

Packaging assembly processes

Bachelor's degree in Engineering or a related technical discipline.

Proficiency with Microsoft Office applications.

Experience in medical device manufacturing.

Familiarity with quality management systems such as ISO 9001 and ISO 13485.

Performance in this role will be measured by:

Successful execution of assigned validation and engineering activities.

Ability to support project timelines without unnecessary rework or delays.

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.

#