Key responsibilities
* design, develop, and optimize manufacturing processes for medical devices.
* lead process validation activities (iq, oq, pq, and ppq).
* characterize, scale, and strengthen processes using doe, spc, six sigma, and lean principles.
* perform process fmea, root cause analysis, and problem-solving to improve process capability (cpk ≥ 1.33).
* coordinate process transfers from r&d to production, ensuring manufacturability and regulatory compliance.
* collaborate with quality and regulatory teams to integrate process controls into the qms and support regulatory submissions (e.g., 510(k)).
* implement continuous improvement initiatives focused on efficiency, cost reduction, and cycle time improvement.
* oversee qualification of equipment, tooling, and external suppliers.
* provide technical support for new product introduction (npi) activities.
* mentor and support junior engineers, promoting best practices and knowledge transfer.
experience
* minimum of 3 years of experience in process engineering within the medical device industry.
* proven experience in process validation, technology transfer, and manufacturing scale-up.
* direct involvement in new product introduction (npi) projects.
* experience working in fda-regulated environments; class ii or iii medical devices preferred.
education
* bachelor's degree in mechanical, biomedical, chemical engineering, or a related field.
* master's degree and/or six sigma black belt certification preferred.
skills and competencies
* strong knowledge of lean manufacturing and six sigma methodologies.
* proficiency with doe, spc, and statistical analysis tools (e.g., minitab).
* solid understanding of regulatory standards such as 21 cfr 820 and iso 13485.
* advanced english (written and verbal) is required for technical communication with global teams and customers.
* strong analytical and data-driven problem-solving skills.
* effective communication and collaboration skills in cross-functional environments.
* technical leadership, mentoring capability, and ability to manage multiple projects in dynamic settings.
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