Staff Design Quality Engineer

Johnson & Johnson MedTech

Galway

Hybrid

EUR 63,000 - 101,000

Full time

10 days ago

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Benefits offered by this job

Hybrid working arrangements

Travel opportunities (5-10%)*

Annual bonus program

Job summary

Johnson & Johnson MedTech in Galway, Ireland, is seeking a Lead Design Quality Engineer to provide design quality leadership across the development lifecycle. You will partner with R&D, regulatory, and manufacturing to ensure regulatory compliance and robust product quality.

You will lead Design Control, risk management, and quality system activities from concept through commercialization and post-launch support, mentoring teammates and shaping global guidelines.

Qualifications

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 Quality Management System processes or sub-processes.
Experience supporting external inspections (FDA and Notified Body).
Experience supporting new product development and lifecycle management activities.

Responsibilities

Lead Design Control and Risk Management activities to ensure compliance with quality system requirements.
Partner with R&D teams to support product development and lifecycle management.
Lead design quality activities for product launches and transfer programs.
Guide teams in applying Design Control and Risk Management processes.
Support design inputs, design outputs, FMEA, verification and validation strategies.

Skills

Design Quality

Leadership

Problem Solving

Communication

Regulatory Knowledge

Education

Degree in Engineering/Science

Tools

CAPA systems

Quality Management Systems (QMS)

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function

Quality

Job Sub Function

R&D/Scientific Quality

Job Category

Professional

All Job Posting Locations

Galway, Ireland

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 leading 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.

Required Skills

Accelerating, Agility Jumps, Coaching, Communication, Compliance Management, Continuous Improvement, Data Savvy, Disaster Recovery (DR), Econometric Models, Issue Escalation, Problem Solving, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Researching

Preferred Skills

The Anticipated Base Pay Range For This Position Is

€63 300,00 - €101 315,00

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.