Engineer, Combination Products & Medical Device - 6376

Job Title:      Engineer, Combination Product & Medical Device

Location:      Columbus, Ohio

Job Type:     Full time

Req ID:          6376

 

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Engineer, Combination Products & Medical Device to join our team.  In this role, you will be responsible for providing Combination Product and Medical Device support and standardization for the Quality System and Design Controls within local operations.  Support includes ensuring that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site.  Implements required documentation and studies to support requirements for development, launch, lifecycle changes, and Business Development (3P) opportunities to meet identified business objectives and targets.  Work is performed with direction in determining technical objectives from both a short-term and long-term perspective for desired results.  You will work closely with Research & Development, Technical Services, Operations, Quality Control, Quality Assurance and Hikma global sites.

 

Key Responsibilities:

Knowledge Management

• Supports the site as a contact with regards to combination products and medical devices and has knowledge of other related disciplines.
• Stays up to date on regulations and regulatory trends to ensure that practices and procedures remain current with regulatory health authorities’ expectations with regards to Combination Products and Medical Devices i.e. 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO14971, etc…
• Supports Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed
• Expands site education with regards to combination products and medical device requirements and organizational processes

Infrastructure Support

• Supports the lifecycle management of the Quality Management System, Processes, and Procedures, to be compliant with all relevant combination product and medical device regulations
• Works within a Combination Product Board to share and align on best practices within local operations.
• Supports Risk Management approach and implementation
• Contributes in relevant Quality Governance meetings

Project Support

• Actively participates on departmental and/or cross-functional teams as Combination Product and Medical Device Subject Matter representative

• Applies technical expertise while supporting the successful completion of project teams.
• Performs gap assessments of processes and procedures against relevant industry / device regulations
• Contributes recommendations and proposals to address technical solutions to problems and interacts with senior personnel on significant matters
• Completes key activities such as risk analysis, FMEA, and hazard analysis for projects