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Job Description
Product Development Engineer for Medical Device and Pharma Testing
Highly skilled engineer required to lead testing and development projects for medical devices and pharmaceuticals, utilizing cutting-edge technologies like 3D printing.
About the Role
Our client's Galway laboratory is seeking an innovative and technically skilled Product Development Engineer to join their engineering team. The successful candidate will manage customer-facing projects, apply problem-solving skills, and contribute to new product development through R&D initiatives.
Key Responsibilities
- Develop, modify, verify, and validate test methods for medical device and pharmaceutical testing.
- Manage multiple complex customer testing projects simultaneously.
- Lead device and packaging testing projects for medical device and pharmaceutical customers.
- Conduct Peel Tests, Torque Tests, and other mechanical tests to ensure product compliance.
- Utilize 3D printing technology in the development of custom test jigs and prototypes.
- Interface with customers and the sales team to assess project feasibility and costings.
- Develop and agree on project plans, test protocols, and methods with customers.
- Coordinate staff and resources to execute testing and deliver results.
- Analyze test results, provide statements of conformity, and offer interpretations.
- Collaborate with the validation team on Test Method Validation studies.
- Assess equipment specifications and suitability for test methods.
- Develop User Requirement Specifications (URS) for laboratory equipment procurement.
- Support the Quality team with investigations, procedure updates, and audits.
- Engage in continuous improvement initiatives and lean processes on-site.
- Involved in coding and automation for test procedures and data analysis.
- Participate in R&D efforts for new product development, contributing innovative ideas and solutions.
Required Qualifications and Experience
- Bachelor's degree in a relevant engineering or technical discipline.
- Proven experience in medical device verification and validation, including regulatory submission projects.
- Demonstrated experience in R&D and new product development.
- Knowledge of 3D printing and its applications in engineering projects.
- Hands-on experience with Peel Tests, Torque Tests, and other testing methods.
- Proficiency in coding for automation and data analysis.
- Proven project management track record.
- Customer-facing experience with strong interpersonal and commercial skills.
- Experience with CAD and Minitab software is an advantage.
- Strong problem-solving skills with a creative, solution-oriented mindset.
Benefits
- Healthcare
- 25 days Annual Leave
- Pension