Sr. Engineer, Advanced Combination Products & Medical Devices

Hikma Pharmaceuticals; Columbus (OH); Sur place; USD 110 000 - 140 000; Plein temps

Avantages offerts par ce poste

Annual performance bonus

401(k) with company match

PTO 20 days

Résumé du poste

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Sr. Engineer, Combination Products & Medical Device to provide CP and device QA framework and design expertise across local and global operations.

You will ensure compliance with 21 CFR Part 820, ISO 13485, and related regulations through lifecycle governance and project leadership. The role requires driving risk management, quality governance, and regulatory readiness while collaborating with internal teams and external partners to support

Qualifications

• Strong SME in combination products and medical devices, including design controls, risk management, validation, reliability, and process controls.
• Deep knowledge of pharmaceutical principles and complex dosage forms.
• Experienced in manufacturing, packaging, and device production processes.
• Able to lead cross-functional teams and manage regulatory activities.

Responsabilités

• Stay up to date on regulations and regulatory trends for combination products and medical devices.
• Develop and maintain a quality management system compliant with regulations.
• Lead risk analyses, FMEA, and threshold analyses for active projects.
• Provide guidance on regulatory responses and health authority interactions.

Connaissances

Combination products

Medical devices

Regulatory knowledge

Quality systems

Risk management

Project management

Cross-functional leadership

Description du poste

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Sr. Engineer, Combination Products & Medical Device to provide CP and device QA framework and design expertise across local and global operations.

You will ensure compliance with 21 CFR Part 820, ISO 13485, and related regulations through lifecycle governance and project leadership. The role requires driving risk management, quality governance, and regulatory readiness while collaborating with internal teams and external partners to support