Project Quality Engineer I – New Product Introduction

About the role

Cirtec Medical is seeking a Project Quality Engineer I to join its New Product Introduction (NPI) team. The engineer will support the design, development, documentation, and validation of new or transferred medical device products, ensuring smooth hand‑offs between sites and compliance with quality standards.

Key responsibilities

• Assist in the development, verification, and testing of new customer products and product modifications.
• Prepare and execute process validation activities and manufacturing transfer plans.
• Collaborate with cross‑functional teams, customers, and suppliers to define requirements, timelines, and deliverables.
• Support documentation creation for design history files, validation reports, and regulatory submissions.
• Participate in site‑to‑site transfer projects, acting as a liaison between sending and receiving locations.

Required profile

• Experience with product or process transfers in a regulated medical‑device environment.
• Strong understanding of design verification, testing builds, and manufacturing workflows.
• Ability to work effectively in cross‑functional teams and communicate technical information clearly.
• Growth mindset, proactive problem‑solving, and willingness to learn.

Required skills

• Design verification
• Process validation
• Manufacturing transfer preparation
• Quality‑system compliance (e.g., ISO 13485, FDA QSR)

What we offer

• Opportunity to work on cutting‑edge Class II and III medical devices.
• Collaborative environment focused on innovation and continuous improvement.
• Professional development and exposure to a broad range of product families.