Staff Design Quality Engineer

About Johnson & Johnson MedTech

Johnson & Johnson MedTech is dedicated to pioneering healthcare innovations aimed at preventing, treating, and curing complex diseases with smarter and less invasive solutions. Their expertise in Innovative Medicine and MedTech positions them uniquely to deliver impactful healthcare advancements worldwide.

Role Overview

We are seeking a Staff Design Quality Engineer to join our Neurovascular MedTech team in Galway, Ireland. This position involves providing expert Design Quality guidance and ensuring compliance throughout new product development, design iterations, and lifecycle management. Collaborating closely with Product Development, Regulatory Affairs, Manufacturing, and cross-functional teams, the incumbent will ensure adherence to relevant regulations and internal standards.

Key Responsibilities

• Lead Design Control and Risk Management initiatives to maintain compliance with quality system standards.
• Collaborate with R&D teams on new product creation and lifecycle maintenance.
• Oversee Design Quality activities related to product launches and design transfer efforts.
• Advise product teams on the practical application of Design Control and Risk Management throughout development and manufacturing stages.
• Assist in defining design inputs, developing outputs, preventing failure modes, and establishing verification and validation plans.
• Support test method creation, validation, comparative testing, process validations, design transfers, and launch planning.
• Ensure critical quality factors translate effectively into design and production specifications.
• Manage risk assessment processes, creating strategies to uphold product safety and performance.
• Deliver quality-related requirements for R&D projects and mentor Design Quality Engineers.
• Coordinate Design Quality resources to align with project and business priorities.
• Apply structured problem-solving techniques to analyze and resolve quality issues.
• Maintain Design Control documentation and support design reviews.
• Review and approve batch documentation, production, and sterilization records linked to Design Control.
• Assist with bench testing and monitor quality management system data for trends and potential issues.
• Lead or facilitate quality system activities such as CAPA and handling non-conformances.
• Prepare metrics and information for management reviews.
• Support audits, inspections, regulatory interactions, including supplier and internal audits.
• Contribute to regulatory submissions and compliance during product development and lifecycle management.
• Deliver Quality System training and foster collaboration with Regulatory Affairs.
• Assist with complaint investigations, escalations, and post-launch CAPA implementations.
• Participate in policy, procedure, metric, and quality process development and improvement.
• Build strong relationships with internal teams, external partners, suppliers, regulators, and stakeholders.
• Provide technical leadership on complex projects and mentor junior colleagues, contributing to organizational quality and regulatory enhancements.

Qualifications and Experience

• Bachelor’s degree in Engineering, Science, or another relevant technical discipline.
• At least 6 years' experience in the medical device, IVD, pharmaceutical, or related regulated industries.
• A minimum of 3 years’ direct involvement with Quality Management System processes.
• Experience supporting regulatory inspections such as FDA and Notified Body audits.
• Hands-on experience with new product development and lifecycle management in regulated environments.

Technical Expertise

• Thorough understanding of Design Control fundamentals and application.
• Proficient in Risk Management principles and methodologies.
• Knowledgeable of 21 CFR Part 820, ISO 13485, and other international medical device regulations.
• Familiarity with sterilization processes, Quality Assurance, Design Control, and product development workflows.
• Understanding of CAPA, non-conformance management, and overall Quality System requirements.

Skills and Attributes

• Ability to juggle multiple projects and priorities effectively.
• Strong analytical and problem-solving skills.
• Capable of working both autonomously and within collaborative multi-functional and global teams.
• Excellent communication, influencing, and interpersonal skills suitable for diverse audiences.
• Adaptability to dynamic environments and commitment to meeting deadlines.
• Awareness of AI concepts and ethical practices, employing effective prompting methods to enhance efficiency.

Work Arrangement

• Position location: Galway, Ireland.
• Hybrid working options may be available.
• International travel expected around 5–10%.

Compensation and Benefits

The gross anticipated base salary range for this role is between €63,300 and €101,315 annually. Additional benefits include an annual bonus based on personal and company performance, vacation leave, parental leave (minimum 12 weeks), bereavement, caregiver and volunteer leaves, wellness reimbursements, and programs for financial, physical, and mental health support. Employees and eligible dependents may also participate in insurance plans and receive recognition awards based on company policies. Benefit details may vary by location and are subject to change.

Diversity and Inclusion

Johnson & Johnson is committed to inclusion and equal opportunity. We welcome qualified applicants from all backgrounds and provide accommodations throughout the recruitment and onboarding processes as needed.