Product Development Engineer – Medical Devices
Supporting the design and development of innovative medical packaging solutions and Contract Pack introductions. You'll develop test methods, support process validation, execute material trials and produce prototype samples for new product introduction (NPI).
Responsibilities
Design and develop new medical packaging product concepts
Produce engineering documents, material specifications and finished goods specifications
Develop URS, FAT, SAT, IQ, OQ, PQ and Risk Management documentation
Build and execute test methods and validation protocols
Support equipment qualification and material validations
Provide technical training to manufacturing personnel
Deliver technical support to the sales team on new product introductions
Requirements
Bachelor's degree or higher in Engineering (Mechanical, Manufacturing, Biomedical or similar)
2–5 years' product development experience in medical devices or pharmaceutical packaging
Experience working in an FDA, ISO 13485 or GMP regulated environment
Strong knowledge of IQ, OQ, PQ validation protocols
Expertise with ISO16890, EN779, EN14683, EN149
Proficiency in statistical analysis and statistical process control (SPC)
Familiarity with design controls, design verification and validation (V&V)
Experience with risk management tools such as FMEA
Strong problem-solving skills with a continuous improvement mindset
Ability to work independently and collaboratively within cross-functional teams
To Apply
This permanent role is managed by Force Recruitment on behalf of Steripack Ireland. Please apply through the link or email shirley.kiernan@forcerecruitment.com for a detailed spec.
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