Senior Manager, Manufacturing Engineering

The Senior Manager, Manufacturing Engineering at Cepheid in Hebron, Kentucky leads a team of manufacturing engineers to optimize production processes, ensure efficient and high-quality manufacturing operations, and support the introduction of new products. This on‑site role reports to the Director, Manufacturing Process Engineer and is part of the Global Engineering team.

Responsibilities

• Drive process improvement by leading initiatives to enhance efficiency, reduce waste, and improve product quality using Lean and Six Sigma methodologies.
• Support production operations by providing hands-on engineering assistance to resolve manufacturing issues, minimize downtime, and ensure smooth operations.
• Oversee New Product Introduction (NPI) by collaborating with R&D to ensure manufacturability and leading process validation and equipment qualification from pilot to full-scale production.
• Implement advanced technologies by evaluating and deploying new equipment and automation solutions to boost manufacturing capability and scalability.
• Ensure quality and compliance by partnering with Quality teams to maintain process controls, conduct root cause analysis and corrective actions (RCA/CAPA), and ensure regulatory compliance.
• Manage projects and foster cross-functional collaboration with Production, Supply Chain, and R&D to drive operational excellence.

Requirements

• Education: Bachelor’s degree in Manufacturing, Industrial, Mechanical, Electrical Engineering, or a related technical field.

• Experience: 8+ years in manufacturing engineering within a GMP environment, including 4+ years in a leadership role.

• Process improvement: Proven success in driving Lean Manufacturing and Six Sigma initiatives; Green or Black Belt certification preferred.

• NPI expertise: Hands-on experience with New Product Introduction, including process development, validation, and equipment qualification.

• Technical knowledge: Strong understanding of manufacturing processes such as assembly, machining, fabrication, automation, and inspection.

• Leadership and problem solving: Demonstrated ability to build and coach teams, with a data-driven approach to decision-making.

• Communication: Strong verbal and written communication skills to convey complex technical concepts to varied audiences.

• Travel and on-site requirements: Ability to travel approximately 20%; valid driver’s license with acceptable driving record.

• Preferred but not required

• cGMP Medtech experience

• Experience with CAD software and statistical analysis tools (e.g., Minitab, JMP)

• Experience in the life sciences or healthcare industry

• Experience with industrial automation (e.g., PLCs, SCADA)

• Knowledge of AI/ML integration with automation

• Master’s degree in engineering or an MBA

• Experience in a regulated industry

• Knowledge of quality systems (e.g., ISO 13485, AS9100, IATF 16949)

• Experience implementing or working with Manufacturing Execution Systems (MES) or ERP systems

• Proficiency in project management