Description

This role serves as the primary technical specialist managing Design History Files and regulatory compliance.

Responsibilities

• Act as the single point of contact for offshore and onsite teams on assigned work streams.
• Interact directly with clients and offshore teams regarding project requirements, deadlines, and escalations.
• Develop Design Inputs documentation (VOC, URS, SRS) and manage Validation Plans and Reports.
• Create and update Design Verification and Design Validation documentation.
• Update and maintain product risk management tools, including Hazard Analysis and dFMEA.

Required Skills

• 7-9 years of professional experience in a relevant 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, including EU-MDR and 21 CFR 820.30.
• Experience managing requirements specification and traceability matrices (URTM, PRTM).
• Proficiency with Agile PLM and MiniTab.
• Familiarity with core medical device standards: IEC 60601-1, 60601-1-2.
• Experience with CAPA, DHF remediation, and DFMEA.
• Strong understanding of technical documentation processes within regulated environments.

Key Skills

Education

Bachelors (or higher) degree in engineering