Project Engineer, Quality Engineering

Description About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

The Project Engineer is primarily responsible for leading a cross‑functional project team that includes Quality, Engineering and Production. This position oversees the development, documentation and validation of new and modified customer products by maintaining established timelines, communicating project status internally and to customers. The Project Engineer also manages transferring projects to Production with a cradle‑to‑grave philosophy for programs. The Project Engineer must meet agreed upon delivery dates and established product requirements while ensuring the greatest level of manufacturability for products transferred to Production.

This position will work closely with members of the Quality Assurance, Manufacturing, Tooling, Materials Science and Process Engineering teams to deliver projects to help achieve organizational goals. This Project Engineer will also work individually and on teams to execute organizational projects for continuous improvement in various manufacturing processes.

• Lead and manage the entire (NPI) New Product Introduction process from concept to commercialization ensuring effective collaboration among all stakeholders.
• Collaborate closely with product development teams to provide input on design for manufacturability, cost‑effective production processes and efficient assembly methods.
• Interface with customers regarding part requirements and mold designs and may serve as a primary contact on projects of moderate complexity.
• Develop and maintain detailed project plans including timelines, milestones and critical path activities. Track and report progress against established goals.
• Coordinate cross‑functional teams including engineering, manufacturing, materials science, procurement and quality assurance to ensure alignment and timely execution of NPI activities.
• Conduct feasibility studies and risk assessments to identify potential challenges and propose appropriate mitigation strategies.
• Collaborate with suppliers and vendors to ensure timely availability of materials, tooling and equipment necessary for NPI projects.
• Design and execute validation and verification plans including process qualifications, equipment validations and product testing to ensure compliance with quality standards and customer requirements.
• Develop and execute process validations (IQ, OQ & PQ). Generate validation completion reports with cross‑functional team including quality and metrology department. Final reports to include:
  • Develop validation protocol activities
  • Dimensional reports and analysis
  • Engineering studies, DOE
  • FMEA, Control Plan, Process Flow
  • Confirmation of all validation activities executed including written procedures
• Drive continuous improvement initiatives to optimize procedures, reduce costs and enhance product quality and manufacturability.
• Maintain accurate documentation including engineering change orders, bill of materials and work instructions to support NPI activities.
• Provide regular project updates to stakeholders including management highlighting progress, risks and proposed solutions.
• Utilize 3D modeling software to examine and form a better understanding of customer supplied models for quoting and/or tooling builds.
• Create quotations on estimated costs for tooling, automation and machinery required for a successful product launch.
• Oversee prototype and material development projects.
• Involvement in design and development of new…