Principal Process Engineer, Advanced Manufacturing Team

Responsibilities

• Serve as the technical authority for advanced manufacturing processes, technologies, and engineering strategies supporting current and future product portfolios.
• Lead the development, implementation, and optimization of complex manufacturing processes for new product introductions and commercialized products.
• Define manufacturing architectures, technology roadmaps, and long-term process strategies aligned with business objectives and growth plans.
• Drive cross-functional collaboration with R&D, Quality, Operations, Supply Chain, Regulatory Affairs, and external partners to ensure successful product commercialization and lifecycle management.
• Identify, evaluate, and implement emerging manufacturing technologies, automation solutions, and digital manufacturing capabilities to improve scalability, quality, and efficiency.
• Lead highly complex process development activities, including process characterization, risk assessments, validation strategies, and technology transfers.
• Establish robust process control strategies utilizing advanced statistical methods, Design of Experiments (DOE), Statistical Process Control (SPC), capability analysis, and data analytics.
• Provide technical leadership for process validation activities (IQ/OQ/PQ), ensuring compliance with FDA, ISO, and global regulatory requirements.
• Lead investigations into critical manufacturing issues, applying advanced root cause analysis methodologies and driving sustainable corrective and preventive actions.
• Champion continuous improvement initiatives utilizing Lean, Six Sigma, and operational excellence methodologies to improve productivity, quality, and cost performance.
• Influence capital planning, equipment selection, facility design, and manufacturing expansion strategies.
• Mentor, coach, and develop engineers across multiple levels while serving as a technical resource and thought leader throughout the organization.
• Lead and influence cross-site or enterprise-wide initiatives that standardize best practices and improve manufacturing capabilities across Medtronic.
• Represent manufacturing engineering in executive-level reviews, strategic planning discussions, and external technical engagements as required.

Must Have

• Minimum Requirements: Bachelor's Degree with a minimum of 7 years of relevant experience OR Advanced Degree with a minimum of 5 years of relevant experience.
• Nice to Have: Extensive experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments; Demonstrated success leading complex manufacturing technology development, process innovation, and commercialization efforts; Strong expertise in automation, robotics, equipment integration, digital manufacturing, or Industry 4.0 technologies; Experience with plastics processing technologies including injection molding, extrusion, or complex assembly manufacturing processes; Proven ability to influence technical strategy and drive alignment across multiple functions, sites, and organizational levels; Advanced knowledge of process validation, risk management methodologies (FMEA), and quality system regulations; Lean Six Sigma Black Belt, Master Black Belt, or equivalent operational excellence experience; Strong analytical, problem-solving, and decision-making skills with the ability to resolve highly complex technical challenges; Demonstrated experience mentoring engineers and leading technical development across engineering organizations; Excellent communication and stakeholder management skills, including the ability to present technical concepts to senior leadership and executive audiences.