Staff Engineer, Process Development

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Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions : Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

The Staff Engineer – Process Development is considered is a senior technical leader and highly experienced individual contributor responsible for leading the development of manufacturing concepts, advanced process designs and comprehensive characterization, optimization, and validation strategies.for medical devices from concept through commercialization. This position contributes to strategic planning and providing technical expertise to support multiple projects or a major segment of the overall portfolio, focusing on Core Manufacturing Process Definition. This drives significant development initiatives ensuring robust, scalable, and compliant processes are in place to support new product introductions and technology transfers into manufacturing Value Streams.

Additionally, the Staff Engineer provides technical guidance across cross-functional teams, influencing product design for manufacturability, leading process development activities, and ensuring compliance with regulatory and quality standards. They are expected to champion innovation and drive complex projects or guide multidisciplinary teams to solve high-impact technical challenges in a regulated environment. Depending on the department, the Staff Engineer may include oversight of project teams and provides significant mentorship of junior engineers and technical staff.

• Technical Leadership :

a. Lead the technical execution of major manufacturing process development programs and strategic initiatives to enable New Product Introduction (NPI) in compliance with TMC Quality System requirements and regulatory standards.

b. Provide domain-specific technical leadership, guidance, and mentorship to engineers and project teams, elevating the technical capabilities of the team.

c. Influence product design from a process perspective at a platform level (DFM / DFA) during early NPI stages.

d. Partner with R&D and Design Engineering teams during early product development to drive the identification, evaluation, and implementation of new process technologies and equipment to improve OEE and reduce manufacturing cost.

e. Solve highly ambiguous and complex technical challenges encountered during NPI and scale-up with no clear precedent.

f. Provide technical mentorship across engineering, R&D, and manufacturing teams.

a. Responsible for developing and maintaining Manufacturing Process Design standards integrating advanced technologies and smart manufacturing principles (automation, process monitoring, data analytics) to advance manufacturing infrastructure.

b. Act as the Subject Matter Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.

c. Drive execution of proof-of-concept definition and determines fundamental manufacturing methods new product introduction processes. Evaluate and drive the technical feasibility of implementing novel technologies and processes for NPI.

d. Drive the technical execution of laboratory-polit scale processes and prototypes into scalable manufacturing processes by identifying critical process parameters (CPPs), material specifications, and equipment needs at platform level.

e. Drive technical execution of process risk analysis (EFMEA, pFMEA) and execute process development strategies including, commissioning (URS / FRS / Traceability Matrix), characterization and validation strategies (IQ / OQ / PQ) in accordance with regulatory and internal standards.

f. Develop novel manufacturing concepts and advanced process designs for new product platforms.

g. Lead the technical execution acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation

h. Integrates DFM and DFA principles across technical teams involved in NPI and manufacturing process design.

i. Lead the assessment of Patent Situation Statements and intellectual property strategy related to manufacturing processes for new products.

j. Drive significant improvements through advanced Lean and Six Sigma methodologies applied to NPI processes.

a. Drive technical execution of design reviews, project planning activities, and formal project reviews.

b. Prepare and present technical presentations to various levels of personnel, ensuring clear communication of technical activities.

c. Efficiently manage resources, including time, budget, and personnel, to ensure successful project completion.

Job Responsibilities (continued)

a. Facilitates scale-up of laboratory or pilot processes to industrial production settings—including specification of equipment, methods, automation, throughput planning, and cost targets.

b. Acts as primary technical advisor for design transfer frameworks ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology transfer documentation.

a. Drive 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 platform level process development initiatives.

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. Strong experience in developing, scaling, and validating manufacturing processes for medical devices or other regulated industries.

b. Mastery in materials, equipment selection, and process technologies such as molding, joining, assembly, laser processing, or other advanced manufacturing methods used in medical device production.

c. Mastery 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 (e.g., FMEA, pFMEA).

f. Proven track record in validation (IQ / OQ / PQ), process mapping, and quality systems is strongly preferred.

g.

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.

c. Proven ability to lead cross-functional technical teams and mentor junior engineers effectively, fostering their technical development. Ability to build consensus and drive technical alignment among diverse stakeholders.

a. Expert-level 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

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, t uition reimbursement, travel assistance, and an employee assistance program. $114,400 - $157,300

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.

Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include : annual bonus, 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.

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