Sr. Engineer, Combination Products & Medical Device

Hikma Pharmaceuticals; Columbus (OH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

20 days PTO

Job summary

Hikma Pharmaceuticals USA Inc. in Columbus, OH seeks a Sr. Engineer for Combination Products and Medical Devices to lead quality-system framework and lifecycle management across local operations and the global organization.

You will ensure compliance with FDA and ISO requirements and guide risk management, design controls, and regulatory readiness. The role emphasizes cross-functional leadership, regulatory interpretation, and collaboration with internal teams and external partners to drive

Qualifications

• BS in engineering field with 10+ years direct experience at a medical device or combination product manufacturer.
• MS in engineering field with 5+ years direct experience at a medical device or combination product manufacturer.

Responsibilities

• Stay current with regulations and regulatory trends to ensure practices meet regulatory expectations.
• Support inspection readiness and responses for regulatory inspections as needed.
• Lead or participate on cross-functional teams as SME for combination products and medical devices.
• Drive risk analysis, FMEA, and other quality activities for active projects.
• Provide guidance for regulatory responses to health authority questions for product approvals.

Skills

FDA regulations

Design controls

Risk management

Cross-functional collaboration

Quality systems

Education

BS in engineering

MS in engineering

Tools

Microsoft Office

Job description

Sr. Engineer, Combination Products & Medical Device

Location: Columbus, OH

Job Type: Full time

We are seeking a talented and motivated Sr. Engineer, Combination Products & Medical Device to join our team.

In this role, you will be responsible for providing Combination Product and Medical Device Quality System Framework and Design expertise both within local operations and to drive best practices within the global organization.

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.

Responsibility also includes assessing, evaluating, identifying and implementing required documentation and studies to support requirements for launch, lifecycle changes and Business Development opportunities to meet identified business objectives and targets.

Key Responsibilities

• 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 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
• Active member of relevant industry groups and key stakeholder organizations
• Direct the work of consultants as needed and mentor others
• Responsible for driving site education with regards to combination products and medical device requirements and organizational processes.

Infrastructure Support

• Develop and ensure lifecycle management of a Quality Management System to be compliant with all relevant combination product and medical device regulations
• Work within a Center of Excellence to share and align on best practices across Hikma Operating Units
• Facilitate and/or supports the development and implementation of combination product and medical device quality governance processes and procedures
• Develops and drives Risk Management approach
• Contributes in relevant Quality Governance meetings

Project Support

• Leads and/or participates on departmental and/or cross-functional teams as Combination Product and Medical Device SME
• Performs gap assessments of processes and procedures against relevant device regulations
• Develops recommendations and proposals to address identified gaps and provides expert guidance for projects
• Drives, as appropriate, key activities such as risk analysis, FMEA and threshold analysis for active projects
• Drive required Statements of Work with consultants where needed to support specific product programs e.g. device reliability, human factor studies, threshold analysis, FMEA, and/or risk analysis
• Drives change control support for Combination Product & Medical Device requirements assessment and deliverable review
• Provide support for relevant investigations and CAPA(s)
• Provides guidance on approach and regulatory responses support for health authority questions to support product approvals

• Other duties as assigned
• Predictable, consistent onsite attendance required

Qualifications

We value the skills and experiences candidates bring to the table. While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• 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

Business & Technical Expertise

• 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.

Customer Focus

• Champions quality and customer service excellence.
• Aligns strategies to customer needs and market trends.
• Establishes best practices to maintain industry-leading service standards.

Innovation & Change Leadership

• Promotes a culture of innovation and continuous improvement.
• Evaluates solutions against business goals and stakeholder impact.
• Drives actionable strategies that enhance productivity and competitive advantage.

Communication & Influence

• Effective communicator across diverse audiences; skilled in presentations, technical writing, and meeting facilitation.
• Proficient in Microsoft Office tools (Word, Excel, PowerPoint, Outlook).

Regulatory & Operational Excellence

• Expert knowledge of pharmaceutical regulations (cGMP, FDA, DEA, ANDA requirements).
• Strong project management experience leading cross-functional teams.
• Able to work independently with minimal supervision.

Preferred Qualifications

• Experience with Class III/lifesaving combination products or medical devices; background in statistics and continuous improvement (Six Sigma Green/Black Belt preferred).
• Strong critical thinking skills with a track record of completing complex projects and developing solutions to minimize risk and resolve issues.
• Proven ability to manage multiple high-complexity projects, influencing cross-functional teams (PD, AD, DRA, Medical, QA, Operations, Warehouse) and external partners while meeting strict timelines.
• Demonstrated decision-making capability, balancing risk vs. reward and independently driving tactical decisions (e.g., formulation, manufacturing processes, QbD strategy, experimental design).
• Contributes to project planning, timelines, and budget adherence aligned with business goals.
• Decisions primarily impact local operations with potential regional/global implications, including influence on regulatory timelines and product launch readiness.
• Evaluates scientific and business risks to guide innovation and strategic direction.

What We Offer

• 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
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.