Senior Design Assurance

Actalent; Galway; In loco; EUR 70.000 - 90.000; Tempo pieno

Descrizione del lavoro

Actalent seeks a Senior Design Assurance Engineer for a medical device client in Ireland. The role focuses on ensuring products meet regulatory and quality standards across R&D, quality, regulatory, and manufacturing.

You will shape verification/validation, risk management and product transfer to manufacturing. You will collaborate across functions to drive CAPA, investigations and continuous improvement, influencing product quality throughout the lifecycle and supporting successful

Competenze

• Degree in Engineering, Science or related STEM field.
• Experience in Medical Device industry.
• Knowledge of FDA & ISO regulatory requirements.
• Experience with DFMEA/PFMEA and risk management.

Mansioni

• Lead and support Design Verification and Design Validation activities.
• Drive Design Controls, Design Review and Design Change processes.
• Support regulatory submissions and compilation of technical documentation.
• Lead CAPA, root cause investigations and continuous improvement initiatives.
• Develop and improve test methods, protocols and engineering documentation.
• Support Human Factors and Usability studies.
• Perform and review risk management activities including DFMEA/PFMEA.
• Support product transfer from design into manufacturing.
• Collaborate with external design, manufacturing and supplier partners.
• Provide technical leadership to cross-functional teams.

Conoscenze

Design Controls

Risk Management

Root Cause Analysis

Regulatory Submissions

Formazione

Engineering/Science degree

Descrizione del lavoro

About the Role

We are recruiting for a Senior Design Assurance Engineer to join an innovative and rapidly growing medical device organisation developing technologies that improve the lives of cancer patients. This is a key hire within the Quality and Product Development team, supporting the expansion of a growing product portfolio as the business transitions from development into commercialisation.

This position sits at the intersection of R&D, Quality, Regulatory Affairs and Manufacturing, ensuring products are developed, tested and commercialised in compliance with medical device regulations and industry standards. You will play a significant role in driving product quality throughout the entire product lifecycle, from concept and development through to verification, validation and manufacturing transfer.

The successful candidate will have the opportunity to work on innovative patient-focused technologies in a fast-paced, collaborative environment where they can have a direct influence on products that improve patient outcomes worldwide.

Key Responsibilities

• Lead and support Design Verification and Design Validation activities.
• Drive Design Controls, Design Review and Design Change processes.
• Support regulatory submissions and compilation of technical documentation.
• Lead and support CAPA, root cause investigations and continuous improvement initiatives.
• Develop and improve test methods, protocols and engineering documentation.
• Support Human Factors and Usability studies.
• Perform and review risk management activities, including DFMEA and PFMEA.
• Support product transfer from design into manufacturing.
• Work closely with external design, manufacturing and supplier partners.
• Provide technical leadership, coaching and guidance to cross-functional teams.

Essential Requirements

• Degree in Engineering, Science or a related STEM discipline.
• Experience within the Medical Device or Healthcare industry.
• Strong understanding of Design Controls, Design Reviews and Design Change processes.
• Experience working within an ISO 13485 Quality Management System.
• Experience with risk management methodologies including DFMEA and PFMEA.
• Strong problem-solving and root cause investigation skills.
• Knowledge of FDA and ISO regulatory requirements.
• Experience creating technical reports, validation protocols, engineering documentation and risk files.
• Excellent communication and stakeholder management skills.
• Ability to work effectively in cross-functional development teams.

Highly Desirable

• IEC 62304 Software Lifecycle experience.
• IEC 60601 Electrical Safety knowledge.
• Experience with software-enabled or electro-mechanical medical devices.
• Previous Design Assurance or Design Quality Engineering experience.
• Experience supporting FDA submissions and regulatory audits.
• Medical device startup or SME experience.
• Test method validation and statistical analysis experience.
• Understanding of ISO 10993 requirements.
• Experience working directly with notified bodies or regulatory agencies.

What They're Looking For

The strongest candidates will combine:

• Medical Device experience
• Design Assurance or Design Quality expertise
• Design Controls knowledge
• IEC 62304 software experience
• IEC 60601 electrical safety exposure
• FDA knowledge
• Startup mentality and hands-on approach
• Strong communication and stakeholder management skills

Beyond the technical requirements, they're looking for someone who is ambitious, proactive, comfortable taking ownership and excited about helping scale a growing medical technology business.