Job Title: Process Development Engineer (Contract Role)
Location: Tipperary, Ireland
Type: Contract (On-site – minimum 4 days per week)
Industry: Medical Device Manufacturing
About the Role:
Our client, a leading medical device company based in Tipperary, is seeking an experienced and hands-on Process Development Engineer for a contracting position. This role is pivotal in supporting new product introduction (NPI) through the development and validation of robust, efficient manufacturing processes.
The ideal candidate will have a strong background in laser manufacturing technologies (welding, cutting, etching) and/or experience with CNC code or CAD/CAM systems. This is a highly technical, onsite-based role that requires a proactive, detail-oriented engineer who thrives in a dynamic and regulated environment.
Key Responsibilities:
* Lead the development and optimization of manufacturing processes to support new product introductions.
* Own and execute all aspects of:
o Process Characterization
o Equipment Qualification (IQ/OQ/PQ)
o Process Validation (VMP, VP, etc.)
o Risk Assessments (e.g., PFMEA)
* Apply technical expertise to design and innovate processes, procedures, tooling, and automation systems.
* Maintain comprehensive documentation throughout all phases of process development in accordance with quality and regulatory standards.
* Communicate effectively on progress, technical challenges, and project risks with internal stakeholders.
* Work collaboratively with cross-functional teams including R&D, Quality, and Manufacturing Engineering.
Key Requirements:
* Strong hands-on experience in laser manufacturing processes (welding, cutting, etching) is highly desirable.
* Experience or working knowledge of CNC code or CAD/CAM systems is strongly preferred.
* Proven track record in process development for medical devices or in similarly regulated industries.
* Solid understanding of validation protocols and risk assessment methodologies.
* Excellent problem-solving and documentation skills.
* Ability to work independently and communicate technical information clearly.
Work Environment:
* This is an on-site role requiring a minimum of 4 days per week on location in Tipperary.
* The position is contract-based, offering the opportunity to contribute to a high-impact project within a globally recognized medical device organization.
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