Sr. Engineer, Combination Products & Medical Device

About the role

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 Sr. Engineer, Combination Products & Medical Device to join our team.

Responsibilities

• 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 to meet identified business objectives and targets.

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 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.
• 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.
• 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