Senior Manufacturing Engineer

Req ID: 361213

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now.

We are currently seeking a Senior Manufacturing Engineer to join our team in Florida, Florida (US-FL), United States (US).

Job Title: Senior Manufacturing Engineer

Location: Florida, USA

Position Summary

We are 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 RD, Quality, and Operations to transition products from concept to full-scale production while ensuring high-quality, compliant, and cost-effective manufacturing processes.

Key Responsibilities

Process Optimization Technical Leadership

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Develop, implement, and optimize manufacturing processes including molding, laser welding, and bonding to improve efficiency, yield, and cost performance.
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Apply Lean Six Sigma methodologies and Design of Experiments (DOE) to drive continuous improvement.
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Create, update, and maintain manufacturing documentation including PFMEAs, Control Plans, SOPs, and Work Instructions in compliance with FDA and ISO 13485 requirements.
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Ensure processes are robust, scalable, and aligned with regulatory and quality standards.

Project Leadership Continuous Improvement

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Lead cross-functional teams on process improvement, cost reduction, and capital equipment acquisition projects.
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Oversee equipment selection, installation, and validation activities (IQ/OQ/PQ).
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Collaborate with suppliers to establish process capability and ensure material and component quality.
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Drive operational excellence initiatives to enhance productivity and reduce manufacturing risk.

Mentorship Technical Guidance

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Provide technical leadership and mentorship to junior engineers, technicians, and production staff.
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Support RD through Design for Manufacturability (DFM) reviews and early-stage process development.
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Develop and deliver training on new equipment, tools, and manufacturing procedures.
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Foster a culture of accountability, innovation, and continuous learning.

Quality Compliance

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Lead root cause analysis (RCA) investigations for production and quality issues using structured problem-solving tools.
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Drive CAPA initiatives and ensure timely, effective resolution of non-conformances.
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Maintain strict adherence to FDA regulations, ISO 13485 standards, and internal quality systems.
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Support internal and external audits as required.

Qualifications

Education

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Bachelor’s degree in Mechanical, Manufacturing, Biomedical, or related Engineering discipline.
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Advanced degree preferred.

Experience

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Minimum of 10+ years of experience in medical device manufacturing.
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Demonstrated experience in regulated environments (FDA, ISO 13485).

Technical Skills

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5+ years of proficiency in CAD software (Creo and/or SolidWorks).
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Strong statistical analysis skills with Minitab or similar tools.
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Working knowledge of Lean Six Sigma principles (certification preferred).
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3 to 5 years of experience with process validation (IQ/OQ/PQ) and DOE methodologies.
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3 to 5 years of hands-on experience with molding, laser welding, bonding, or similar precision manufacturing processes.

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start-up partners. NTT DATA is a part of NTT Group, which invests over $3 billion each year in RD.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in-office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees. NTT DATA recruiters will never ask for payment or banking information and will only use @nttdata.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us.

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