Terumo Medical Corporation · 1 month ago
Staff Engineer, Process Development
Elkton, MD
Full-time
Onsite
Senior Level, Lead/Staff
$114K/yr - $186K/yr
10+ years expTerumo Medical Corporation is a leader in healthcare innovation, seeking a Staff Engineer in Process Development. This role involves leading the development of manufacturing processes for medical devices, providing technical guidance, and ensuring compliance with quality and regulatory standards.
HardwareHealth CareHealth DiagnosticsIndustrial ManufacturingManufacturingMedicalMedical Device
Hiring Manager
Julia Campbell
Responsibilities
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
Provide domain-specific technical leadership, guidance, and mentorship to engineers and project teams, elevating the technical capabilities of the team
Influence product design from a process perspective at a platform level (DFM/DFA) during early NPI stages
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
Solve highly ambiguous and complex technical challenges encountered during NPI and scale-up with no clear precedent
Provide technical mentorship across engineering, R&D, and manufacturing teams
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
Act as the Subject Matter Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes
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
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
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
Develop novel manufacturing concepts and advanced process designs for new product platforms
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
Integrates DFM and DFA principles across technical teams involved in NPI and manufacturing process design
Lead the assessment of Patent Situation Statements and intellectual property strategy related to manufacturing processes for new products
Drive significant improvements through advanced Lean and Six Sigma methodologies applied to NPI processes
Drive technical execution of design reviews, project planning activities, and formal project reviews
Prepare and present technical presentations to various levels of personnel, ensuring clear communication of technical activities
Efficiently manage resources, including time, budget, and personnel, to ensure successful project completion
Facilitates scale-up of laboratory or pilot processes to industrial production settings—including specification of equipment, methods, automation, throughput planning, and cost targets
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
Drive technology transfers and knowledge-sharing across internal manufacturing sites and external partners (CMOs, equipment suppliers)
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
Attend business meetings, prepare minutes, communications, and reports, ensuring effective stakeholder communication
Work collaboratively with cross-functional teams, including engineers, quality assurance, and production staff, to ensure seamless integration of automation solutions
Represent NPI Engineering in platform level process development initiatives
Perform other job-related duties when assigned
Qualification
Required
Strong experience in developing, scaling, and validating manufacturing processes for medical devices or other regulated industries
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
Mastery of Design for Manufacturability (DFM), process characterization, DOE, and statistical analysis
Familiarity with automation, Industry 4.0 concepts, and equipment integration a strong plus
Strong knowledge of FDA regulations, ISO 13485, GMP, and risk management practices (e.g., FMEA, pFMEA)
Proven track record in validation (IQ/OQ/PQ), process mapping, and quality systems is strongly preferred
Exceptional ability to learn new technologies and explain complex engineering problems to non-engineering personnel
Proficiency in creating and delivering presentations to executive management and preparing detailed technical reports for regulatory bodies like the FDA
Proven ability to lead cross-functional technical teams and mentor junior engineers effectively, fostering their technical development
Expert-level in root cause analysis, troubleshooting, and resolution of complex manufacturing and product development issues
Proficient in tools such as Minitab, JMP, and MS Office Suite; working knowledge of CAD and PLM systems is a plus
Effective use of MS Office Suite and CAD software
Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or related field
10+ years in process development, manufacturing engineering, or product development, with at least 10 years in the medical device or other highly regulated industry
Preferred
Master's degree preferred
Lean Six Sigma Black Belt (SSBB) are desirable
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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