Process Engineer

Cirtec Medical - Sturtevant, WI

Full-time - Entry Level

Sturtevant, WI

Miscellaneous Manufacturing

About the position

The Engineer I, Process Development at Cirtec Medical is responsible for leading a functional project engineering group that encompasses various engineering disciplines. This role focuses on the design, development, documentation, and validation of new customer products, as well as modifications to existing products. The engineer will define requirements, timelines, and deliverables, with an emphasis on prototypes, process development, design verification, clinical builds, and preparation for process validation and manufacturing transfer.

Responsibilities

• Attend and arrange project meetings to discuss current and future design and development initiatives.
• Track and communicate issues and status on assigned action items that would affect timelines and budget.
• Manage project inputs such as feasibility builds, documentation, and testing.
• Select equipment and develop processes with appropriate documentation.
• Conduct device verification samples and testing.
• Provide operator training and perform Process Failure Mode Effects Analysis.
• Oversee clinical builds and process validation activities.
• Participate in product design and specification creation, including mechanical and electrical components, assemblies, and packaging.
• Source materials and develop device prototypes.
• Conduct design verification and validation activities, including data for regulatory submission.
• Support manufacturing transfer and existing product lines as applicable.
• Comply with company, quality, and safety standards, policies, and procedures.
• Perform other duties as assigned.

Requirements

• Bachelor's Degree required with 0 years of experience.