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 eng…
Skills: NPI, Program management, Process engineering, Medical device manufacturing, FDA regulations
Job Summary The Product Development Engineer III is responsible for leading the design, development, and improvement of complex products, ensuring quality and compliance with technical and regulatory requirements. This r…
Provide quality leadership and guidance throughout new product development, technology transfers, and product launch activities.Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, and other applicable…
Skills: Quality Engineering, NPI, FDA QSR, ISO 13485, ISO 14971
Resumen del Puesto** El Ingeniero Senior de Calidad (Calidad de Proveedores) será responsable de asegurar la calidad de los componentes y materiales suministrados por nuestros proveedores, implementando y manteniendo sis…
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Full-time
bachelor degree
Posted 2d ago
~40 hrs/week
Responsibilities
The Engineering Manager will lead the full NPI program from transfer through production launch, ensuring cross-functional alignment and process validation. They are responsible for managing customer relationships, mitigating program risks, and developing a team of NPI engineers.
Requirements
Candidates must hold a Bachelor's degree in Engineering and possess significant experience in NPI or program management within a medical device manufacturing environment. Proficiency in FDA regulations, ISO 13485, and process validation is required, along with bilingual fluency in English and Spanish.
Full 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 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
Improving Lives through Medical Device Innovation.
At ATL Technology, we are the trusted partner of choice for leading medical device OEMs worldwide. With over 30 years of expertise, we excel in designing, developing, and manufacturing innovative medical devices that improve and save lives.
Our commitment to engineering excellence and unwavering dedication to quality drive us to deliver cutting-edge solutions across various medical fields. From electrosurgical instruments and camera-based imaging devices to high-density interconnect technologies, we offer a wide range of specialized products and services.
Our vertically integrated capabilities empower us to collaborate with OEMs at any stage of development, from concept to mass production. We pride ourselves on fostering innovation through robust partnerships and comprehensive support, ensuring our customers' success in an ever-evolving healthcare landscape.
At ATL Technology, we understand that it's not just about technology; it's about the people behind it who drive real change in healthcare. Join us in our mission to protect and enhance lives through groundbreaking medical device innovation.
Innovation. Expertise. Excellence. ATL Technology.
Offices: 1335 W 1650 N, Springville, Utah 84663, US · Xi Xing Road, XiTou Village, Kang Le Nan Main Road, HouJie Town, Dong Guan City, Guan Dong Province 523952, CN · 9F-8, #736 Chung Cheng Rd., Chung Ho City, Taipei Hsien, TW · Flexi Park, Bodega E 10, San Rafael Alajuela, CR · 7 Fortran Rd, St. Mellons, Cardiff CF3 0LT, GB
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