Senior Engineer, Combination Products, Medical Device

Hikma Pharmaceuticals

Sr. Engineer providing combination product and medical device quality expertise for Hikma Pharmaceuticals.

Posted 6/10/2026full-timeColumbus • Ohio • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Provide Combination Product and Medical Device Quality System Framework and Design expertise both within local operations and to drive best practices within the global organization
Ensure that all applicable Combination Product and Medical Device regulations are incorporated within corporate and local procedures and are adequately implemented within the manufacturing site
Assess, evaluate, identify and implement required documentation and studies to support requirements for launch, lifecycle changes and Business Development opportunities
Stay 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
Support Combination Product and Medical Device inspection readiness and regulatory inspection responses as needed
Develop and ensure lifecycle management of a Quality Management System to be compliant with all relevant combination product and medical device regulations
Facilitate and/or supports the development and implementation of combination product and medical device quality governance processes and procedures
Lead and/or participate on departmental and/or cross-functional teams as Combination Product and Medical Device SME
Perform gap assessments of processes and procedures against relevant device regulations
Provide guidance on approach and regulatory responses support for health authority questions to support product approvals

Requirements

What you’ll need

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 understanding of business development, lifecycle management, and long-term planning
Subject matter expert 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 (e.g., nasal suspensions, dry powder inhalers, novel delivery systems)
Experienced in manufacturing, packaging, and device production processes
Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook)

Benefits

Comp & perks

Annual performance bonus, commission, and share potential
Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 4% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
3 personal days (prorated based on hire date)
11 company paid holidays
Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
Employee discount program
Wellbeing rewards program
Career advancement and growth opportunities
Tuition reimbursement
Paid maternity and parental leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

quality management systemdesign controlsrisk managementvalidationreliabilityprocess controlslifecycle managementbusiness developmentmanufacturing processespackaging processes

Soft Skills

leadershipcross-functional collaborationcommunicationproblem-solvingorganizational skills