Engineering Manager

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

What You Will Own:

Program Leadership: 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, and supply chain

Customer Relationship: 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

Process Validation: 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

Cross-Functional Alignment: 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

Team Leadership: Lead, develop, and inspire a team of NPI engineers — setting clear expectations, providing regular feedback, and building the technical capability of the team

Risk Management: Identify, communicate, and mitigate program risks early — never letting a risk become a surprise. Escalate blockers proactively and drive resolution with urgency

Production Readiness: Ensure the production line, operators, equipment, documentation, and quality controls are fully ready before production begins — no shortcuts, no surprises

Continuous Improvement: Drive lessons learned after every program phase — building a stronger, faster, and more reliable NPI process with every program we complete

What We Are Looking For:

Experience and Education:

Bachelor's degree in Engineering — Mechanical, Industrial, Biomedical, or related field required

Eexperience 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

Technical Skills:

Strong understanding manufacturing processes — medical and catheter manufacturing experience is a significant plus

Proficiency in program management tools — integrated program plans, milestone tracking, risk registers, and action logs

Working knowledge of FDA regulations, ISO 13485, and GMP requirements

Experience with PFMEA, control plans, and process validation documentation

Ability to read and interpret engineering drawings, specifications, and technical documentation

Leadership and Behavioral Competencies:

Makes and meets commitments: When you commit to a milestone or a deliverable, you deliver. Your word matters and your team and your customers know it

Drives with urgency: You move fast, you prioritize ruthlessly, and you do not wait to be told what to do next

Communicates proactive: You surface risks early, you never let a problem become a surprise, and you communicate clearly and consistently with your team and your customers

Solves root causes: You do not accept workarounds or band-aids when a real solution is possible. You dig until you find the root cause and you fix it

Builds trust: With your team, with your customers, and with the broader organization. You are the person people count on when it matters most

Develops people: You invest in your team, you give honest feedback, and you build the capability of the people around you

One ATL mindset: You see yourself as part of a broader team — not just your program or your function. You support your colleagues and you show up as a partner to the full site

Language:

Fluent in Spanish and English — written and verbal. The ability to communicate effectively with both the local Costa Rica team and the global engineering and customer teams is essential

Our Mission to is partner with the world's leading medical device companies to accelerate the development and manufacturing of innovative medical devices. We look for employees who live our values; Honesty, Excellence, Accountability, Respect & Teamwork (HEART) as a part of their daily interactions with customers, peers and their communities.

Introduce Yourself!