Senior Engineer, Combination Products & Medical Devices

RXinsider LTD.; Columbus (OH); On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Annual performance bonus

401(k) with match

20 days PTO

Personal days

11 company holidays

Health, dental, vision benefits

Employee discount program

Wellbeing rewards program

Career growth opportunities

Tuition reimbursement

Paid parental leave

Safety and quality priority

Job summary

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Engineer for Combination Products & Medical Device to lead quality system design, lifecycle management, and regulatory alignment across global operations.

You will drive risk management, design controls, and cross-functional collaboration to ensure compliant product development and lifecycle support. The role requires deep expertise in FDA regulations (cGMP, QSR), ISO standards, and a strong track record in medical device manufacturing, including

Qualifications

• B.S. in engineering field (e.g. pharmacy, chemical, medical device, packaging or mechanical) with 10+ years direct experience at a medical device manufacturer or combination product manufacturer.
• M.S. in engineering field with 5+ years direct experience at a medical device manufacturer or combination product manufacturer.
• Strong knowledge of design controls, risk management, validation, reliability, and process controls.

Responsibilities

• Stay current on regulations and regulatory trends for Combination Products and Medical Devices.
• Lead lifecycle management of a Quality Management System compliant with relevant regulations.
• Direct cross-functional teams as Combination Product and Medical Device SME.
• Drive risk analysis, FMEA, and threshold analyses for active projects.
• Support change control and CAPA related to product requirements.
• Provide regulatory responses support for health authority questions.

Skills

Combination product knowledge

Medical device quality systems

Regulatory compliance

Education

B.S. in engineering

M.S. in engineering

Tools

Quality management tools

Job description

Hikma Pharmaceuticals USA Inc. is seeking a Sr. Engineer for Combination Products & Medical Device to lead quality system design, lifecycle management, and regulatory alignment across global operations.

You will drive risk management, design controls, and cross-functional collaboration to ensure compliant product development and lifecycle support. The role requires deep expertise in FDA regulations (cGMP, QSR), ISO standards, and a strong track record in medical device manufacturing, including