Sr. Engineer, Combination Products & Medical Device

Sr. Engineer, Combination Products & Medical Device

Location: Columbus, OH

Job Type: Full time

Req : 11621

We are seeking a talented and motivated Sr. Engineer, Combination Products & Medical Device to join our team. In this role, you will 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. Your responsibilities include ensuring that all applicable regulations are incorporated within corporate and local procedures and are implemented within the manufacturing site.

You will also assess, evaluate, and implement required documentation and studies to support launch, lifecycle changes, and Business Development opportunities.

• Stay up to date on regulations and regulatory trends to ensure practices and procedures remain current with regulatory health authorities’ expectations regarding Combination Products and Medical Devices (e.g., 21 CFR Part 820 QSR, 21 CFR Part 4, ISO 13485, ISO
  14971).
• Supports inspection readiness and regulatory inspection responses as needed.
• Active member of relevant industry groups and key stakeholder organizations.
• Direct the work of consultants and mentor others.
• Responsible for driving site education regarding combination products and medical device requirements and organizational processes.

• Develop and ensure lifecycle management of a Quality Management System compliant with all relevant regulations.
• Work within a Center of Excellence to share and align best practices across operating units.
• Facilitate and support the development and implementation of quality governance processes and procedures.
• Develop and drive Risk Management approach.
• Contribute in relevant Quality Governance meetings.

• Lead and/or participate on departmental and cross‑functional teams as SME.
• Perform gap assessments of processes and procedures against regulations.
• Develop recommendations and proposals to address identified gaps and provide expert guidance for projects.
• Drive 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.
• Support change control for requirements assessment and deliverable review.
• Provide support for investigations and CAPA.
• Provide guidance on approach and regulatory responses for health authority questions to support product approvals.
• Other duties as assigned.
• Predictable, consistent onsite attendance required.

• B.S. in an engineering field (e.g., pharmacy, chemical, medical device, packaging or mechanical) with 10+ years direct experience at a medical device or combination product manufacturer.
• M.S. in an engineering field with 5+ years direct experience at a medical device 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.
• 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).
• Strong project management experience leading cross‑functional teams.
• Able to work…