Job Summary

The Principal Engineer – New Product Introduction is a highly experienced expert role responsible for driving cross-functional strategy from design concept through successful commercialization and global manufacturing deployment. This position involves providing strategic inputs and technical expertise to support a portfolio of projects, focusing on Overall Product Launch Orchestration & Design Transfer Strategy. This role plays a critical part in ensuring the successful integration of all elements (product design, process, automation, quality controls, supply chain, logistics) for successful, scalable, cost-effective, and compliant new product introductions and technology transfers into manufacturing Value Streams. In addition to the above, The Principal Engineer provides strategic technical guidance across product platforms leads global design transfer initiatives and drives Lean Six Sigma and process excellence throughout the product lifecycle. They are expected to independently lead complex projects or guide multidisciplinary teams to solve high-impact technical challenges in a regulated environment. Depending on the department, this role may include oversight of project teams or mentorship of junior engineers and technical staff.

Job Details/Responsibilities

1. Technical Leadership: a. Lead the overall strategic plan and execution for design transfer and launch readiness of new products into manufacturing, coordinating all activities from development to full-scale production in in compliance with TMC Quality System requirements and regulatory standards. b. Provide strategic guidance and technical direction in management and executive meetings, contributing to department strategies and initiatives. c. Partner with the Project Management Office (PMO), Product Development, Process Development, Quality, Marketing, Regulatory Affairs, Operations, Supply Chain, Logistics and Distribution teams to align product requirements with global production capabilities and ensure successful product launches. d. Ensure new products are designed for efficient and cost-effective manufacturing by working closely with product development teams on Design for Manufacturability (DFM) principles. e. Provide technical mentorship and lead resolution of complex new product/process issues across NPI engineering, R&D, and manufacturing teams. f. Ensure all newly transferred products meet FDA regulations, ISO standards, GMP requirements specific to medical devices and all national regulations. 2. New Product Introduction and Innovation

a. Lead the transfer of technology and processes for new products from Research and Development (R&D) to manufacturing, ensuring a smooth and efficient transition of knowledge, documentation, and equipment. b. Develop and implement New Product Introduction and Transfers standards integrating technology benchmarking activities to advance manufacturing infrastructure and design transfer excellence. c. Serve as the New Product Introduction project technical lead developing design transfer and scale up plans ensuring on-time and within-budget delivery. d. Provide technical support to various departments regarding new products, process issues, and customer feedback, and support the business acquisition process with technical information and costing data. e. Conduct thorough risk assessments and implement mitigation strategies for potential issues throughout the new product introduction process, addressing product functionality, reliability, safety, and manufacturing scalability.

Job Responsibilities (continued)

3. Project Planning and Execution: a. Lead process commissioning, characterization, qualification, and validation activities for new product introductions. b. Support equipment performance monitoring and evaluation for new product manufacturing processes. c. Support design reviews, project planning activities, and formal project reviews. d. Prepare and present technical presentations to various levels of personnel, ensuring clear communication of technical activities. e. Efficiently manage resources, including time, budget, and personnel, to ensure successful project completion. 4. Process Excellence a. Champion continuous improvement through lean six sigma manufacturing principles, and systems thinking for platform level solutions. b. Serve as the Subject Matter Design for Lean Six Sigma in new product introduction processes. c. Lead broad process improvement initiatives to enhance team efficiency and functionality. 5. Cross-Functional Collaboration: a. Lead technology transfers and knowledge-sharing across internal manufacturing sites and external partners (CMOs, equipment suppliers). b. Foster effective working relationships with senior engineers and leaders in Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing to ensure process readiness and effective product launch. c. Attend business meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication. d. Work collaboratively with cross-functional teams, including engineers, quality assurance, and production staff, to ensure seamless integration of automation solutions. e. Represent NPI Engineering in global new product introduction, product transfer initiatives and strategic planning. 6. Perform other job-related duties when assigned.

Working Conditions/Physical Requirements

This position will be located in the Terumo facility located in Elkton, MD. The position will perform required duties in an office environment, the Product Development Laboratory and Process Pilot area, and within manufacturing areas. Access to hospitals and hospitals operating rooms might be required to meet with clinicians and observe relevant clinical procedures associated with new product development activities.

Knowledge, Skills and Abilities (KSA)

Technical Leadership: a. Extensive experience in New Product Introduction (NPI) Process, Risk Management and Technology Transfer processes for medical devices or other regulated industries. b. Expertise in manufacturing process architecture, value stream transformation supply chain, logistics and distribution optimization for medical device commercialization. c. In-depth understanding of Design for Manufacturability (DFM), process characterization, DOE, and statistical analysis. d. Familiarity with automation, Industry 4.0 concepts, and equipment integration a strong plus. e. Strong knowledge of FDA regulations, ISO 13485, GMP, and risk management practices (., FMEA, pFMEA). f. Experience with validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred. g. 2. Communication Skills: a. Exceptional ability to learn new technologies and explain complex engineering problems to non-engineering personnel. b. Proficiency in creating and delivering presentations to executive management and preparing detailed technical reports for regulatory bodies like the FDA. 3. Problem-Solving Skills: a. Demonstrated strength in root cause analysis, troubleshooting, and resolution of complex manufacturing and product development issues. b. Proficient in tools such as Minitab, JMP, and MS Office Suite; working knowledge of CAD and PLM systems is a plus. c. Effective use of MS Office Suite and CAD software.

Qualifications/ Background Experiences

1. Education: Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field. Master’s degree preferred.

2. Experience: 20+ years in process development, manufacturing engineering, or product development, with at least 10 years in the medical device or other highly regulated industry.

3. Certifications: Lean Six Sigma Black Belt (SSBB) is required, Lean Sigma Master Black Belt and Project Management Professional (PMP) are desirable.

Benefits / Compensation

We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include: paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. $133,000 - $182,800