Senior Product Engineer
medtronic · San Isidro
Job description
About the role
Medtronic seeks a Senior Product Engineer to support high‑volume manufacturing and commercialization of medical devices. The role focuses on sustaining engineering, process improvement, validation, and cross‑functional collaboration to ensure product quality and regulatory compliance.
Key responsibilities
- Provide production support for manufacturing processes, testing methods, specifications, and yield improvement initiatives.
- Analyze customer complaints, returns, nonconformances and supplier changes to identify root causes and implement corrective actions.
- Lead process, product verification and validation activities to meet quality and regulatory requirements.
- Develop and execute benchtop testing protocols, fixtures and validation plans, documenting results in technical reports.
- Perform statistical analysis for process capability, design evaluation, improvement and risk mitigation.
Required profile
- Bachelor’s degree in Biomedical, Mechanical or related engineering discipline.
- Minimum 4 years of relevant engineering experience (or Master’s with 2 years, or PhD with no experience).
- Experience in medical device product development, manufacturing or commercialization.
- Professional fluency in English for technical documentation and cross‑functional communication.
Required skills
- Material science principles and hands‑on process characterization.
- Design of Experiments (DOE) and statistical data analysis (Minitab, ANOVA, regression, CpK/PpK).
- Interpretation of engineering drawings, GD&T and tolerance stack‑up analysis.
- Knowledge of FDA, ISO 13485, design controls and medical device regulatory requirements.
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Published 5 hours ago
Expires 1 month from now
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medtronic
San Isidro
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