Director – Device Engineering (MSAT)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

DESCRIPTION:
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 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 companys 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.

How you will make an impact:

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

What you will do:

Strategic & Technical Leadership

• 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

Device Industrialization & Commercialization

• 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

Validation & Process Excellence

• 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

Quality & Regulatory Leadership

• Ensure compliance with global regulatory requirements including ISOCFR 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

Network & Matrix Leadership

• 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

Capability Building & Talent Development

• 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

Innovation & Continuous Improvement

• Benchmark industry trends emerging technologies and regulatory changes
• Drive adoption of automation and advanced manufacturing solutions and digital tools and data analytics (e.g. CPV process monitoring)
• Identify and lead initiatives to improve cost of goods process efficiency and product quality and reliability

How you will get here:

• Bachelors degree in Engineering Physics or related discipline (or equivalent experience)
• 1215 years of experience in device or combination product development and manufacturing
• Proven leadership experience in MSAT Engineering or Technical Operations
• Deep expertise in device design assembly and tooling development; manufacturing process development and validation; and regulatory requirements for medical devices and combination products
• Strong knowledge of ISO 13485 and 21 CFR Part 820 design controls (DHF/DMR) and technology transfer and commercialization processes
• Demonstrated ability to lead across global matrix organizations influence senior stakeholders and executive leadership and drive strategic initiatives and organizational change

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Director