Senior NPI Process Development Engineer

Senior NPI Process Development Engineer

Location: Ballybrit, Galway
Contract: 12 months
Reports to: NPI Process Development Engineering Manager (Supply Chain)

Role Overview

A leading medical technology manufacturer is seeking a Senior NPI Process Development Engineer to join its team in Galway. This role supports the development, scaling, and commercialisation of complex neurovascular medical devices used in the treatment of acute ischemic stroke.

The successful candidate will be a core member of cross-functional teams responsible for delivering new products from early concept through to full manufacturing readiness. This includes working closely with product development groups, raw material suppliers, external manufacturing partners, and internal engineering teams to ensure that component, assembly, and process solutions meet required performance, quality, and cost targets.

Key Responsibilities

Product & Process Development

• Collaborate with cross-functional teams to ensure robust product designs that support capable, efficient manufacturing processes (Design for Manufacture).

• Translate critical-to-quality requirements into clear component specifications.

• Evaluate new and existing materials, components, and assemblies for technical and manufacturing suitability.

• Lead design-for-manufacture and design-for-assembly improvements across components and sub-assemblies.

Supplier & Prototype Management

• Assess supplier technical capabilities and support supplier selection.

• Manage prototype builds and develop test strategies to support characterisation and development activities.

• Develop and validate new or improved manufacturing processes at supplier and pilot-line level.

• Work with suppliers and incoming inspection teams to define and validate inspection methods.

Risk, Compliance & Change Control

• Identify and mitigate project risks to ensure continuity of supply, quality, and delivery timelines.

• Monitor and support supplier performance, providing technical direction when required.

• Implement changes within the established change management framework.

• Support documentation, reporting, and compliance activities throughout the product lifecycle.

Continuous Improvement & Project Execution

• Drive improvements in yield, efficiency, and manufacturability.

• Prepare and execute validation strategies including FMEAs, protocols, and reports.

• Develop project schedules, manage resources, and support cross-functional execution.

• Conduct statistical analyses and apply structured problem-solving techniques.

Required Qualifications & Experience

• Degree in Mechanical Engineering, Biomedical Engineering, or related discipline.

• 5–7 years experience in medical device process development, product development, or manufacturing in a regulated environment.

• Strong understanding of new product introduction, validation requirements, and full product lifecycle processes.

• Experience developing or validating manufacturing processes, including authoring FMEAs, protocols, and technical documentation.

• Skilled in structured problem-solving methodologies (e.g., Six Sigma, DMAIC).

• Proven experience working with external suppliers or OEMs.

Desirable Experience

• Background in catheter-based medical devices or minimally invasive technologies.

• Experience in Design for Manufacture, Lean assembly methods, SolidWorks, prototyping, and test method development.

• Strong statistical analysis capability throughout all phases of development.

• Demonstrated project management experience.

• Excellent communication, technical writing, and multi-tasking skills.

• Strong initiative, creativity, and problem-solving mindset.

What This Opportunity Offers

• The chance to contribute to innovative medical technologies that impact patient outcomes.

• A dynamic and collaborative working environment with exposure to cutting-edge research and product development.

• Opportunities to work on high-impact projects and gain further technical and professional development.

• A culture that values diversity, wellbeing, inclusion, and continuous improvement.