NPI Engineer - Quality

Mason Alexander; Wexford; On-site; EUR 65,000 - 85,000; Full time

Job summary

Mason Alexander is seeking an experienced NPI Quality Engineer III for a permanent role at a global medical device site in New Ross, Wexford. The role focuses on supporting product development from a quality perspective and contributing to design assurance throughout the PD phases.

You will engage in test method development, process validation (IQ, OQ, PQ), DV testing and report writing, while researching and introducing new technologies and equipment to enhance NPI quality activities.

Qualifications

• Bachelor's degree in an engineering discipline is required or may be considered with additional relevant experience.
• At least 3 years in an engineering role in a medical device company (R&D, product development, process or quality).
• Experience with test method development and process validation is essential.
• Candidates should have strong problem-solving abilities and good communication skills for internal/external stakeholders and project management.

Responsibilities

• New Product Introduction Support: apply engineering concepts for complex problem solving, design & carry out new tooling, testing, fixtures and templates.
• Carry out testing and validation of new test methods including gage R&R studies and statistical analysis of data using software like Minitab.
• Support Site Quality Activities: assist internal audits, readiness, CAPAs and QMS.
• Support planning and execution of risk management activities per ISO14971.
• Stay updated with latest technologies and equipment relevant to NPI, testing and design assurance to improve efficiency of NPI quality activities.

Skills

Complex problem solving

Strong communication

Project management

Education

Bachelor's degree in engineering

Tools

Minitab

Gage R&R

Job description

Global Medical Device development & manufacturing company with a site in New Ross Wexford are seeking an experienced NPI Quality Engineer to join their Design Assurance Team on a permanent basis.

The role focuses on supporting various product development projects from a quality perspective. You would be working as part of a core team through the PD phases, including test method development, process validation (IQ,OQ,PQ), DV testing and report writing.

As the NPI Quality Engineer III, you would also research and introduce new innovative technologies and equipment.

Responsibilities:

• New Product Introduction Support: apply engineering concepts for complex problem solving, design & carry out new tooling, testing, fixtures and templates.
• Carry out testing and validation of new test methods including gage R&R studies and statistical analysis of data through software packages such as Minitab.
• Support Site Quality Activities: support internal audits & readiness, CAPAs, QMS.
• Support planning execution of risk management activities per ISO14971.
• Remain up to date with latest technologies, tools and equipment relevant to NPI, testing, design assurance to improve efficiency of NPI quality activities.

Requirements:

• Bachelors Degree in an Engineering discipline or related degree maybe considered based on additional years of relevant experience.
• At least 3 years of experience in an engineering role in a medical device manufacturing company with focus on R&D, product development, process or quality engineering.
• Experience with test method development and process validation is critical to be considered for this role.
• Complex problem solving skills.
• Strong communication skills for internal & external stakeholder & project management.