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:

  • Process Characterization

  • Equipment Qualification (IQ/OQ/PQ)

  • Process Validation (VMP, VP, etc.)

  • 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.