Principal Engineer- Advanced Operations

The Principal Advanced Operations Engineer - Technical Lead is a senior technical leader responsible for driving manufacturing excellence, process development, technology transfer, and operational readiness for new product launches. As the primary manufacturing and operations engineering authority within R&D, this role leads cross-functional initiatives to enhance manufacturability, improve operational performance, and accelerate commercialization. The position requires expertise in manufacturing engineering, process validation, lean manufacturing, automation, quality systems, and project leadership.

Key Responsibilities:

• Serve as the technical lead for advanced manufacturing and operations engineering initiatives supporting new product development, implementation, and commercialization.

• Provide strategic direction for manufacturing process development, optimization, scale-up, operational readiness, and technology transfer to production.

• Partner with R&D throughout the product development lifecycle to ensure manufacturability and scalability and drive engineering best practices through Design for Manufacturing (DFM) and Design for Assembly (DFA).

• Lead continuous improvement initiatives focused on safety, quality, delivery, and cost performance.

• Lead equipment qualification and process validation activities, including IQ/OQ/PQ execution.

• Collaborate with Quality, Supply Chain, Manufacturing, Regulatory Affairs, and R&D to deliver successful product launches and process implementations.

• Lead multidisciplinary project teams, influence organizational stakeholders, and drive alignment on technical and operational decisions.

• Provide technical expertise in lean manufacturing, Six Sigma, advanced manufacturing processes, automation, and process validation methodologies.

Qualifications:

Required:

• Bachelor's degree in Engineering or related field.

• 8+ years of progressive experience in manufacturing engineering, operations, or new product implementation.

• 5+ years leading complex technical projects and cross-functional teams.

Preferred:

• Master's degree.

• Experience in regulated industries.

• Experience with process validation, equipment qualification, lean manufacturing, and continuous improvement methodologies.

• Experience influencing both leaders and individual contributors cross functionally.