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Job Description
Product Development Engineer for Medical Device and Pharmaceutical Testing: Develop innovative solutions for medical device and pharmaceutical testing, utilizing cutting-edge technologies like 3D printing.
Galway Laboratory is seeking a skilled Product Development Engineer to join their engineering team. This role involves providing key testing and technical services to the medical device and pharmaceutical industries.
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.
This position offers a fantastic opportunity for a problem-solving engineer who is eager to work at the forefront of medical device testing and new product development.
Galway Laboratory is a forward-thinking company that values innovation and collaboration.
Benefits include:
- Healthcare
- 25 days Annual Leave
- Pension