NPI Program Lead for Medical Devices

ATL Technology CR Ltda; Atlanta (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

ATL Technology CR Ltda is seeking a seasoned NPI Program Leader to own the full lifecycle from transfer to production launch. You will drive an integrated program plan, milestones, risk management, and cross-functional alignment across engineering, quality, operations, supply chain, and global program management.

You will lead IQ/OQ/PQ validation under FDA and ISO 13485, collaborate with customers as the technical PM, and develop a high‑performing NPI team while escalating blockers with urgency.

Qualifications

• Bachelor's degree in Engineering — Mechanical, Industrial, Biomedical, or related field required.
• Experience in NPI, program management, or process engineering in a medical device manufacturing environment.
• Direct experience leading IQ, OQ, and PQ validation in an FDA regulated and ISO 13485 environment.
• Experience managing cross-functional teams and driving programs in a complex, fast-paced manufacturing environment.
• Experience working directly with customers in a technical program management capacity.
• PMP certification is a plus but not required.

Responsibilities

• Own the full NPI program from transfer through production launch — driving the integrated program plan, milestone tracking, risk management, and cross-functional alignment across engineering, quality, operations, supply chain.
• Serve as the primary technical point of contact for the customer during the NPI process — building trust through consistent communication, proactive risk escalation, and reliable delivery on commitments.
• Lead IQ, OQ, and PQ execution in compliance with FDA and ISO 13485 requirements — ensuring the process is validated, documented, and ready for production before a single unit ships to the customer.
• Drive alignment across engineering, quality, operations, supply chain, and global program management — ensuring all functions are engaged, accountable, and moving together toward the program milestones.
• Lead, develop, and inspire a team of NPI engineers — setting clear expectations, providing regular feedback, and building the technical capability of the team.
• Identify, communicate, and mitigate program risks early — never letting a risk become a surprise. Escalate blockers proactively and drive resolution with urgency.
• Ensure the production line, operators, equipment, documentation, and quality controls are fully ready before production begins — no shortcuts, no surprises.
• Drive lessons learned after every program phase — building a stronger, faster, and more reliable NPI process with every program we complete.

Skills

Cross-functional leadership

Program management

Communication

Risk management

Team leadership

Education

Bachelor's degree in Engineering

Tools

Program management tools

Job description

ATL Technology CR Ltda is seeking a seasoned NPI Program Leader to own the full lifecycle from transfer to production launch. You will drive an integrated program plan, milestones, risk management, and cross-functional alignment across engineering, quality, operations, supply chain, and global program management.

You will lead IQ/OQ/PQ validation under FDA and ISO 13485, collaborate with customers as the technical PM, and develop a high‑performing NPI team while escalating blockers with urgency.