Medical Device Product Engineer – Sustaining & R&D

Uniting Holding; Leinster; On-site; EUR 65,000 - 90,000; Full time

Job summary

Uniting Holding is seeking a Product Engineer to sustain medical device products at our ProVerum Manufacturing facility in Galway. You will collaborate with Engineering, Operations, Quality and Regulatory teams to ensure R&D projects comply with ISO 13485 and FDA CFR 820 requirements.

You will work hands-on in a cross-functional, growing team, supporting CAPA and process improvements while maintaining documentation and regulatory compliance for PMA/510(k products.

Qualifications

• Degree qualified in an engineering or related technical field.
• Minimum 3 years’ experience in medical device industry, preferably with electromechanical devices containing software.
• Experience in product/process validation and design verification/validation.
• Project planning and execution skills are an advantage.
• Excellent communication and writing skills.

Responsibilities

• Support Operations team in sustaining manufacturing line, troubleshooting during builds and CAPA/NCR investigations.
• Partner with Operations and Quality to design and optimise manufacturing processes and production flow.
• Design, development, verification and implementation of process improvements and process aids/fixturing.
• Assist with test and evaluation of new designs including development iterations.
• Own CAPA, NC and SCAR processes with root-cause analysis and corrective actions.
• Provide technical support to suppliers to ensure supply reliability and quality.
• Develop scale-up plans including reducing cost of goods.
• Develop packaging in conjunction with R&D.
• Support production activities, calibrations, IQ and preventive maintenance.
• Ensure compliance with QMS and regulatory requirements for PMA and 510(k) products.
• Maintain documentation for DHF, QMS procedures and validation reports.
• Compile documentation to support sustaining/development activities per MDD and ISO13485.

Skills

Engineering degree

Medical device industry experience

Validation

Design verification

Project management

Communication skills

Mechanical design

Electronics and software knowledge

CAD - SolidWorks

Coaching

Regulatory knowledge ISO13485/FDA CFR

Education

Engineering degree

Tools

SolidWorks

Job description

Uniting Holding is seeking a Product Engineer to sustain medical device products at our ProVerum Manufacturing facility in Galway. You will collaborate with Engineering, Operations, Quality and Regulatory teams to ensure R&D projects comply with ISO 13485 and FDA CFR 820 requirements.

You will work hands-on in a cross-functional, growing team, supporting CAPA and process improvements while maintaining documentation and regulatory compliance for PMA/510(k products.