Description

You manage Design History Files and ensure regulatory compliance for medical device projects.

This role is on-site.

Responsibilities

• Act as the primary technical contact for offshore and onsite teams, managing work streams, deadlines, and escalations.
• Develop Design Inputs documentation, including Voice of Customer (VOC), User Requirements Specification (URS), and Software Requirements Specification (SRS).
• Create and maintain Validation Plans, Reports, Design Verification, and Design Validation documentation.
• Manage product risk management tools, performing Hazard Analysis and dFMEA updates.

Required Skills

• 7-9 years of professional experience in an engineering discipline.
• Bachelor's degree or higher in Engineering (Mechanical, Bio-Medical, or Electro-Mechanical preferred).
• Expertise in Design Controls, Risk Management (ISO 14971), and ISO 13485 compliance.
• Deep knowledge of medical device guidelines, specifically EU-MDR and 21 CFR 820.30.
• Experience managing requirements specification and traceability matrices (URTM, PRTM).
• Proficiency with Agile PLM and MS Office.
• Familiarity with core medical device standards: IEC 60601-1 and 60601-1-2.
• Experience with CAPA, DHF remediation, and DFMEA.

Preferred Skills

• Proficiency with MiniTab for statistical analysis.

Key Skills

Education

Bachelors (or higher) degree in engineering