Development Engineer – Base Business

About the role

We are seeking a detail‑oriented and technically strong Sustaining Engineer to support ongoing product lifecycle activities, ensuring performance, quality, and compliance of existing medical devices. The role provides engineering support across quality, manufacturing, and regulatory functions, including investigation of nonconformances, complaints, and corrective actions.

Key responsibilities

• Provide engineering support for Non‑Conforming Material Reports (NCMR), CAPA investigations, complaint handling and Health Hazard Evaluations.
• Support sustaining engineering projects, including line extensions and internal/supplier manufacturing transfers.
• Develop and maintain 3D CAD models and SolidWorks drawings for design changes and product improvements.
• Collaborate with cross‑functional teams (Product Development, Manufacturing, Quality, Regulatory, Purchasing, Marketing) to define requirements and execute projects.

Required profile

• Bachelor’s degree in Mechanical, Biomedical or related engineering.
• Experience in medical device or other highly regulated industries.
• Proficiency with Microsoft Word, Excel and Project.
• Strong analytical and problem‑solving abilities.

Required skills

• SolidWorks (3D CAD modeling).
• Microsoft Word, Excel, Project.
• FDA 510(k) submission support.
• Knowledge of ISO 13485 and 21 CFR 820.
• Root cause analysis, CAPA and complaint handling.