Terumo Medical Corporation · 3 days ago
Senior Process Engineer
Elkton, MD
Full-time
Onsite
Mid, Senior Level
$95K/yr - $138K/yr
6+ years expTerumo Medical Corporation is a company focused on advancing healthcare with innovative solutions. They are seeking a Senior Process Engineer to manage and execute technical projects within the New Product Introduction framework, ensuring the design and validation of robust manufacturing processes.
HardwareHealth CareHealth DiagnosticsIndustrial ManufacturingManufacturingMedicalMedical Device
Hiring Manager
Julia Campbell
Responsibilities
Under minimum guidance designs, develops, integrates, and validates new or modified manufacturing processes in compliance with TMC Quality System requirements and regulatory standards
Applies advanced engineering principles and technical knowledge to process developments design and validation efforts
Possess working understanding of Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes
Provides guidance and mentorship to junior engineers and technicians on specific project tasks and methodologies within NPI projects
Maintain Manufacturing Process Design standards
Contributes to the use of Design For Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes
Contributes to the definition and documentation of critical process parameters (CPPs) and material specifications for new manufacturing processes
Contribute to assessing the proof-of-concept for manufacturing methods for NPI
Contributes to the 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
Contribute to the process risk analysis (EFMEA, pFMEA) and execute process development activities including, commissioning (URS/FRS/Traceability Matrix), characterization and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards
Execute activities required for the acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation
Apply knowledge of industry's common business transaction systems (e.g., SAP, MES, Change Control, Ariba)
Use Lean and Six Sigma tools applied to NPI processes
Manages technical tasks and deliverables for assigned projects, ensuring completion within scope and schedule
Contributes to project planning, including estimating task duration and identifying technical risks
Execute scale-up of laboratory or pilot processes to industrial production settings—including specification of equipment, methods, automation, throughput planning, and cost targets for assigned NPI projects
Execute under the design transfer framework for assigned projects ensuring seamless transition of processes from R&D to manufacturing, including creation of DHF elements and technology transfer documentation
Collaborates effectively with cross-functional teams including Project Management Office (PMO), Product Development, Operations Engineering, Quality, and Manufacturing
Attend project team meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication
Communicates technical information effectively within the project team and to immediate supervision
Qualification
Required
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field
6+ years in process development, manufacturing engineering, or product development, with at least 3 years in the medical device or other highly regulated industry
Solid experience in developing, scaling, and validating manufacturing processes for medical devices or other regulated industries
Strong understanding of materials, equipment selection, and process technologies such as molding, joining, assembly, laser processing, or other advanced manufacturing methods used in medical device production
Strong understanding of Design for Manufacturability (DFM), process characterization, DOE, and statistical analysis
Understanding of FDA regulations, ISO 13485, GMP, and risk management practices (e.g., FMEA, pFMEA)
Clear and effective communication of technical information within the project team and to immediate supervision
Proficient in preparing technical documentation
Strong understanding of root cause analysis, troubleshooting, and resolution of complex manufacturing and product development issues
Experience with tools such as Minitab, JMP, and MS Office Suite; working knowledge of CAD and PLM systems is a plus
Preferred
Master's degree desirable
Lean Six Sigma Green Belt (SSGB) are desirable
Familiarity with automation, Industry 4.0 concepts, and equipment integration a strong plus
Experience in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred
Benefits
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
Employee assistance program
Company
Terumo Medical Corporation
Our Promise At Terumo, everything starts with our unwavering commitment to patients.
1001-5000 employees
H1B Sponsorship
Terumo Medical Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2024 (5)
2023 (2)
2022 (2)
2021 (4)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Shahnawaz Khan
CTO & Head of IT
Michael J M.
Sr. VP, Medcal Affairs, Chief Medical Officer
Recent News
Orchestra BioMed Holdings, Inc.
2025-10-28
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