Principal Process Engineer, Advanced Manufacturing Team
Listed on 2026-06-13
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Engineering
Manufacturing Engineer, Process Engineer, Quality Engineering
We anticipate the application window for this opening will close on - 22 Jun 2026.
A Day in the LifeAs a Principal Process Engineer on the Advanced Manufacturing Engineering (AME) team, you will serve as a recognized technical leader responsible for defining and advancing manufacturing strategies that enable the successful development, commercialization, and scale-up of life‑saving medical technologies worldwide.
In this highly visible role, you will drive the development and deployment of innovative manufacturing technologies, establish technical direction for complex engineering initiatives, and influence cross‑functional decision‑making across product development, operations, quality, and supply chain organizations.
You will leverage deep technical expertise to solve complex manufacturing challenges, accelerate new product introduction (NPI), and enhance operational excellence across the organization.
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.
- Bachelor’s Degree with a minimum of 7 years of relevant experience.
- Advanced Degree with a minimum of 5 years of relevant experience.
- 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…
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