Director – Device Engineering; MSAT

Work Schedule

Standard (Mon-Fri)

Office

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Join us as a Director of Device engineering at Thermo Fisher Scientific, where you will guide a diverse global team dedicated to delivering exceptional customer support and training solutions. In this key role, you will develop and execute the vision, strategy, and roadmap for our technical support and training organization, ensuring seamless product support across our portfolio. You will oversee the implementation of new product introduction processes, manage customer satisfaction metrics, and develop innovative training solutions using advanced technologies.

This position offers the opportunity to collaborate with Commercial, R&D, and Marketing teams while guiding initiatives that directly impact our customers' success and our company's growth. Your leadership will be essential in maintaining our commitment to excellence in customer service and technical support across global markets.

The Director of Device Engineering provides strategic, technical, and organizational leadership for device and combination product industrialization within the MSAT organization. This role is accountable for defining and deploying robust, scalable, and compliant device manufacturing strategies to enable successful global product launches. You will act as a network Subject Matter Expert (SME), working across Development, Quality, Operations, and Commercial teams to ensure device designs are manufacturable, compliant, and optimized for commercial scale.

This role drives standardization, capability building, and continuous improvement across the organization while influencing senior stakeholders and site leadership teams.

You will provide strategic, technical, and organizational leadership for device and combination product industrialization.

• Define and implement device engineering and industrialization strategy across programs and sites
• Establish best practices and standards for Design for Manufacture & Assembly (DFM/A), validation, and technology transfer
• Lead development of technology roadmaps for device assembly, molding, automation, and inspection systems
• Provide strategic input into product feasibility, manufacturing strategy, and cost-of-goods optimization

• Oversee end-to-end device industrialization, including early-stage design for manufacturability assessments, assembly process development (pre-assembly, final assembly, inspection), and technology transfer from development to commercial manufacturing
• Ensure successful scale-up and commercial launch execution across device and combination products
• Drive right-first-time launches through robust process design and risk mitigation

• Establish and govern validation strategies (IQ/OQ/PQ, CPV) for device assembly processes
• Oversee process characterization and definition of critical process parameters (CPPs)
• Ensure consistent application of risk management (pFMEA, control strategies) and statistical and data-driven approaches to process control
• Drive continuous improvement in process robustness, yield, and efficiency

• Ensure compliance with global regulatory requirements, including ISO 13485, 21 CFR Part 820, and EU MDR (as applicable)
• Provide leadership during regulatory inspections and audits
• Oversee lifecycle management of Design History Files (DHF) and Design Master Records (DMR)
• Partner with Quality to reduce compliance risk and implement best practices across sites

• Act as global SME for device engineering within MSAT
• Influence and lead cross-functional and cross-site teams through matrix leadership
• Partner with Site Leadership Teams and General Managers to align on priorities and execution
• Drive harmonization and standardization of device engineering practices across the network

• Develop and implement training strategies and curricula for device engineering and MSAT teams
• Build organizational capability in device assembly and tooling, validation and regulatory compliance, and advanced manufacturing technologies
• Mentor and develop future technical leaders and SMEs

• Benchmark industry trends, emerging technologies, and regulatory changes
• Drive adoption of automation and advanced…