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Job Description:

We are searching for the best talent for a Lead Design Quality Engineer.

Purpose

We are looking for a Lead Design Quality Engineer to join our MedTech Neurovascular team in Galway, Ireland.

In this role, you will provide Design Quality technical and compliance expertise to support new product development, design changes, and lifecycle management activities. Working closely with Product Development, Regulatory Affairs, Manufacturing, and other multi-functional teams, you will help ensure products are developed and maintained in compliance with applicable regulations and company requirements.

This role provides leadership in Design Control, Risk Management, and Quality System activities, supporting product development from concept through commercialization and post-launch activities.

You will be responsible for

In this role, you will lead Design Quality activities supporting new product development and lifecycle management programs. You will work closely with R&D and multi-functional partners to ensure Design Control and Risk Management requirements are applied effectively and consistently throughout product development and manufacturing processes.

You will provide guidance on global medical device regulations and help teams interpret and apply Design Control and Risk Management requirements to support compliant product development and commercialization activities.

Key responsibilities include:

• Leading Design Control and Risk Management activities to ensure compliance with applicable quality system requirements
• Partnering with R&D teams to support new product development and product lifecycle management activities
• Leading Design Quality activities associated with product launches and design transfer programs
• Guiding product development teams in the effective application of Design Control and Risk Management processes
• Supporting identification of design inputs, development of design outputs, failure mode prevention activities, and verification and validation strategies
• Supporting test method development, validation activities, competitive testing, process validation, design transfer, and launch planning
• Ensuring critical-to-quality requirements are identified and translated into design and process specifications
• Developing and maintaining risk management processes and risk control strategies to support product safety and performance
• Managing and delivering Quality-related requirements for R&D projects
• Providing Quality guidance and support to project teams and Design Quality Engineers
• Coordinating Design Quality resources, as needed, to support project and business priorities
• Applying structured problem-solving methodologies to investigate, prioritize, communicate, and resolve quality issues
• Maintaining Design Control records and supporting design review activities
• Reviewing and approving R&D batch documentation, production records, and sterilization records supporting Design Control activities
• Supporting bench testing activities, as required
• Monitoring Quality Management System data and communicating potential issues or trends
• Leading or facilitating Quality System activities, including CAPA and non-conformance processes
• Preparing information and metrics for management review activities
• Supporting audits, inspections, and regulatory interactions as required
• Supporting internal and supplier audits
• Supporting regulatory activities related to product development and lifecycle management projects
• Developing and delivering Quality System training, as directed
• Collaborating with Regulatory Affairs on submissions and regulatory deliverables
• Supporting complaint investigations, escalation activities, and post-launch CAPA activities
• Participating in the development and improvement of policies, procedures, metrics, and quality processes
• Building strong relationships with internal and external partners, suppliers, regulators, and stakeholders

As a Lead Design Quality Engineer, you will also provide technical leadership for complex projects, mentor less experienced colleagues, and contribute to the development of Quality and Regulatory guidelines across the organization.

Qualifications / Requirements

We are looking for someone who combines strong Design Quality expertise with leadership, collaboration, and problem-solving skills.

Education & Experience

• Degree in Engineering, Science, or another relevant technical field
• Minimum 6 years of experience in the medical device, IVD, pharmaceutical, or related regulated industry
• Minimum 3 years of experience with direct responsibility for Quality Management System processes or sub-processes
• Experience supporting external inspections, including FDA and Notified Body inspections
• Experience supporting new product development and product lifecycle management activities

Technical Knowledge

• Strong knowledge of Design Control requirements and processes
• Strong knowledge of Risk Management principles and methodologies
• Working knowledge of 21 CFR Part 820 and ISO 13485 requirements, with familiarity of additional international medical device regulations
• Knowledge of sterilization, Quality Assurance, Design Control, and product development processes
• Understanding of CAPA, non-conformance management, and Quality System requirements

Skills

• Ability to manage numerous projects and priorities simultaneously
• Strong analytical and problem-solving capabilities
• Ability to work independently and collaboratively within multi-functional and global teams
• Strong communication, influencing, and relationship-building skills
• Ability to communicate clearly and effectively with technical and non-technical audiences
• Ability to work effectively in a dynamic environment and meet project timelines
• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative and inclusive environment where innovation, learning, and professional development are encouraged.

In this role, you will have the opportunity to contribute to innovative medical technologies, work with global teams, and support products that help improve patient outcomes around the world.

Additional role information

• Location: Galway, Ireland
• Hybrid working arrangements may be available
• International travel of approximately 5–10% may be required

Our commitment to inclusion

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation is powered by bringing together people with different backgrounds, experiences, and perspectives.

We are proud to be an equal opportunity employer and welcome applications from qualified candidates of all backgrounds.

If you require a reasonable accommodation during the application, interview, or onboarding process, support is available. Please let us know how we can help.

#LI-Hybrid

Required Skills:

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.