Sr Manufacturing Engineer

NTT DATA's Client is seeking an experienced Senior Manufacturing Engineer to lead complex process improvement initiatives, provide technical mentorship, and drive quality and operational excellence within a regulated medical device manufacturing environment. This role partners cross-functionally with R&D, Quality, and Operations to transition products from concept to full-scale production while ensuring high-quality, compliant, and cost-effective manufacturing processes.
Spanish speaking is mandatory for this role.
Key Responsibilities Process Optimization & Technical Leadership Develop, implement, and optimize manufacturing processes Apply Lean Six Sigma methodologies and Design of Experiments (DOE) to drive continuous improvement. Create, update, and maintain manufacturing documentation including PFMEAs, Control Plans, SOPs, and Work Instructions in compliance with FDA and ISO 13485 requirements. Ensure processes are robust, scalable, and aligned with regulatory and quality standards. Project Leadership & Continuous Improvement Lead cross-functional teams on process improvement, cost reduction, and capital equipment acquisition projects. Oversee equipment selection, installation, and validation activities (IQ/OQ/PQ). Collaborate with suppliers to establish process capability and ensure material and component quality. Drive operational excellence initiatives to enhance productivity and reduce manufacturing risk.
Mentorship & Technical Guidance Provide technical leadership and mentorship to junior engineers, technicians, and production staff. Support R&D through Design for Manufacturability (DFM) reviews and early-stage process development. Develop and deliver training on new equipment, tools, and manufacturing procedures. Foster a culture of accountability, innovation, and continuous learning. Quality & Compliance Lead root cause analysis (RCA) investigations for production and quality issues using structured problem-solving tools. Drive CAPA initiatives and ensure timely, effective resolution of non-conformances. Maintain strict adherence to FDA regulations, ISO 13485 standards, and internal quality systems. Support internal and external audits as required.
Qualifications Education Bachelor's degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline. Advanced degree preferred.
Experience Minimum of 10+ years of experience in medical device manufacturing. Demonstrated experience in regulated environments (FDA, ISO 13485).
Technical Skills 5+ years of proficiency in CAD software (Creo and/or SolidWorks). Strong statistical analysis skills with Minitab or similar tools. Working knowledge of Lean Six Sigma principles (certification preferred). 3 to 5 years of experience with process validation (IQ/OQ/PQ) and DOE methodologies.

About NTT DATA Services:
NTT DATA Services is a recognized leader in IT and business services, including cloud, data and applications, headquartered in Texas. As part of NTT DATA, a $30 billion trusted global innovator with a combined global reach of over 80 countries, we help clients transform through business and technology consulting, industry and digital solutions, applications development and management, managed edge-to-cloud infrastructure services, BPO, systems integration and global data centers. We are committed to our clients' long-term success. Visit nttdata.com or LinkedIn to learn more.
NTT DATA Services is an equal opportunity employer and considers all applicants without regarding to race, color, religion, citizenship, national origin, ancestry, age, sex, sexual orientation, gender identity, genetic information, physical or mental disability, veteran or marital status, or any other characteristic protected by law. We are committed to creating a diverse and inclusive environment for all employees. If you need assistance or an accommodation due to a disability, please inform your recruiter so that we may connect you with the appropriate team.
Where required by law, NTT DATA provides a reasonable range of compensation for specific roles. The starting hourly range for this remote role is ($55 - 62/hourly ) . This range reflects the minimum and maximum target compensation for the position across all US locations. Actual compensation will depend on several factors, including the candidate's actual work location, relevant experience, technical skills, and other qualifications.
This position is eligible for company benefits that will depend on the nature of the role offered. Company benefits may include medical, dental, and vision insurance, flexible spending or health savings account, life, and AD&D insurance, short-and long-term disability coverage, paid time off, employee assistance, participation in a 401k program with company match, and additional voluntary or legally required benefits.