Design Qualification Engineer

Job Title: Design Qualification SME – Combination Product (CDMO)

Location: Midwest, USA (Onsite/Hybrid Support Considered)

Employment Type: Contract W2 Only no C2C or H1B

Industry: Pharmaceutical / Combination Products / CDMO

Overview:

A leading CDMO is preparing to manufacture a combination medical device for a key client and requires a Design Qualification Subject Matter Expert (SME) to provide strategic and hands-on support as the project enters Phase 2 and beyond.

The successful candidate will bring deep experience in combination product development, with a strong understanding of design qualification, regulatory compliance, and risk-based documentation strategies. This role is critical in ensuring a smooth path through verification, validation, and commercialization.

Key Responsibilities:

• Lead design qualification efforts for a combination product, with specific focus on Phase 2 readiness and scale-up
• Develop and oversee verification and validation planning, including traceability matrices and risk-based documentation strategies
• Support the development of PPQ protocols and ensure alignment of operations (including SA25) with regulatory and quality requirements
• Provide coaching and technical mentorship to the internal team to reinforce understanding of design control principles and combination product expectations
• Ensure all documentation and activities are stage-appropriate and compliant with FDA and global regulatory guidance for combination products

Requirements:

• Proven experience supporting combination product development within a CDMO or similar setting
• In-depth understanding of design control, design qualification, and applicable combination product regulations (21 CFR Part 4, ISO 13485, etc.)
• Strong knowledge of verification, validation, risk management, and traceability requirements
• Experience developing and reviewing PPQ protocols and working with automated systems such as SA25 is preferred
• Ability to engage both strategically and hands-on, with excellent communication and documentation skills