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You will be updated with latest job alerts via emailAbout the role
As a Technical Leader in Convatecs Infusion Care division you will serve as the subject matter expert and strategic driver for critical injection molding tool projects that underpin the development and supply of advanced subcutaneous drug delivery systems. Your role will be pivotal in ensuring technical excellence regulatory compliance and innovation across a global tooling portfolio that supports therapies for chronic conditions such as diabetes and Parkinsons disease. You will lead the technical direction of mold design fabrication and validation collaborating closely with internal stakeholders and external toolmakers to deliver robust high-precision tooling solutions. With a deep understanding of medical-grade polymers regulatory standards and manufacturing processes you will ensure that all technical aspects of tooling projects are controlled optimized and aligned with Convatecs quality and performance expectations. This is a high-impact role for a hands-on technical leader who thrives in a fast-paced regulated environment and is passionate about delivering trusted medical solutions that improve lives.
Main responsibilities
The technical lead is responsible for but not limited to the following tasks:
Lead technical oversight of injection mold tool design fabrication and qualification to meet stringent medical device standards.
Ensure process control and consistency including mold performance dimensional accuracy and material compatibility.
Collaborate with cross-functional teams (R&D Quality Manufacturing) to align tooling solutions with product requirements.
Troubleshoot and resolve technical issues during mold trials validation and production ramp-up.
Review and approve mold designs ensuring manufacturability longevity and compliance with regulatory standards.
Support validation activities including IQ/OQ/PQ protocols and documentation for regulatory submissions.
Drive continuous improvement in tooling performance cycle time and defect reduction.
Liaise with external toolmakers and suppliers ensuring technical requirements are clearly communicated and met.
Maintain technical documentation including mold specifications change records and maintenance logs
Deep expertise in injection mold tooling including design fabrication and optimization for high-precision medical components.
Hands-on experience with mold validation and troubleshooting including root cause analysis and corrective actions.
Strong knowledge of medical-grade polymers and their behavior during molding processes.
Proficiency in CAD and simulation tools such as SolidWorks NX and Moldflow for design review and analysis.
Familiarity with regulatory standards including ISO 13485 FDA 21 CFR Part 820 and validation protocols (IQ/OQ/PQ).
Experience collaborating with cross-functional teams including R&D Quality Manufacturing and external toolmakers.
Excellent documentation and communication skills especially for technical reports change control and audit readiness.
Track record of continuous improvement with exposure to lean manufacturing or Six Sigma methodologies.
Qualifications/Education
Bachelors degree in mechanical engineering plastics engineering or a related technical field.
Extensive hands-on experience with injection mold tool design fabrication and troubleshooting.
Strong understanding of medical device regulations including ISO 13485 and FDA 21 CFR Part 820.
Proficiency in CAD software (e.g. SolidWorks NX) and mold flow simulation tools.
Knowledge of validation protocols including IQ/OQ/PQ and documentation for regulatory compliance.
Familiarity with materials science especially medical-grade polymers and their molding behavior.
Excellent problem-solving skills and the ability to lead root cause investigations and corrective actions.
Strong communication and collaboration abilities especially when working with cross-functional teamsand external toolmakers.
Continuous improvement mindset with training in lean manufacturing or Six Sigma being advantageous
Fluent English level
Travel Requirements
Position may involve travel up to 15% of the time mostly within overseas but Europe travel is expected. Most trips will include overnight travel.
What youll get
Ready to join us
At Convatec were pioneering trusted medical solutions to improve the lives we touch. If youre ready to make a real impact apply today and help us bring our Forever Caring promise to life.
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Equal opportunities
Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race religion creed color national origin nationality citizenship ancestry sex age marital status physical or mental disability affectional or sexual orientation gender identity military or veteran status genetic predisposing characteristics or any other basis prohibited by law.
Notice to Agency and Search Firm Representatives
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Full-Time