Summary
The Senior NPI Process Development Engineer will be a core member of cross-functional teams responsible for developing and delivering complex medical device projects from initial concept through to commercialisation. The role involves working closely with product development teams, suppliers of raw materials, and manufacturers to develop and validate robust processes that ensure high-quality, efficient, and cost-effective production.
Key Responsibilities
* Collaborate on cross-functional teams to ensure designs are optimised for manufacturability (Design for Manufacture).
* Translate critical-to-quality requirements into component specifications ensuring consistent performance.
* Assess and qualify new and existing suppliers for technical and manufacturing capabilities.
* Lead process and product improvements related to design for manufacture and assembly.
* Manage prototype builds, characterisation activities, and develop validation strategies.
* Develop and validate manufacturing processes and inspection methods with external suppliers.
* Identify and mitigate project risks to maintain supply, quality, and schedule targets.
* Monitor supplier performance and provide technical support to resolve production issues.
* Implement process or design changes in compliance with change management systems.
Required Qualifications & Experience
* Degree in Mechanical, Biomedical, or related Engineering discipline.
* 5–7 years’ experience in medical device process or product development within a regulated environment.
Desirable Skills
* Experience in catheter process design or manufacturing.
* Strong understanding of product lifecycle and validation requirements for new product introduction.
* Expertise in validation strategy development, including FMEAs, protocols, and reports.
* Proficiency in structured problem-solving (Six Sigma, DMAIC).
* Project management experience, including scheduling and resource planning.
* Experience collaborating with external suppliers and OEMs.
* Knowledge of Design for Manufacture, Lean assembly, SolidWorks, prototyping, and test method development.
* Competence in using statistical tools throughout project lifecycles.
* Excellent communication, technical writing, and reporting skills.
* Ability to manage multiple projects and work independently with strong problem-solving skills.
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