About Convatec
**About the role**
**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**
- Bachelor’s 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 you’ll**g**et**
- Competitive salary + bonus
- Training & development
- Collaborative, supportive culture
**Ready to join us?**
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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.
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📌 Technical Lead (Del Norte)
🏢 Convatec
📍 Del Norte