Dip Molding Engineer

Mayo to recruit a Dip Molding Engineer. This is a permanent opportunity to take a lead role in developing and establishing a specialised dip molding process for medical device balloons, from initial process development and equipment specification through to validation and optimisation.

• Develop and establish a dip molding process for the manufacture of specialised medical device balloons.
• Conduct process trials and optimise key parameters, including material viscosity, dipping techniques, withdrawal speeds and curing cycles.
• Evaluate materials and formulations to ensure consistent product quality and performance.
• Specify and support the procurement of dipping equipment, automation and associated tooling.
• Work with design engineers and external suppliers to develop and refine mandrels and product fixtures.
• Develop and execute process and equipment validation activities, including IQ, OQ and PQ.
• Prepare technical documentation, validation protocols and SOPs.
• Lead process investigations, root-cause analysis and CAPA activities.
• Ensure processes meet relevant medical device quality and regulatory standards, including ISO 13485 and FDA requirements.

• Degree in Engineering, ideally Polymer, Biomedical, Materials Science, Chemical or Mechanical Engineering.
• Minimum 3 years' hands-on experience in dip molding or medical-grade polymer dip coating.
• Experience with thin-wall components or medical device balloons would be an advantage.
• Knowledge of medical-grade polymers and silicone materials, including LSR, HCR and RTV dispersions.
• Experience in process development, equipment specification and validation (IQ/OQ/PQ).
• Knowledge of medical device quality standards and regulatory requirements.
• Strong problem-solving, technical writing and communication skills.
• Ability to work effectively with cross-functional teams and external suppliers.