Engineering Manager

• 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

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 proactively: 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