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Engineering Manager
ATL TechnologyEngineering Manager leading medical-device NPI programs from transfer through production launch for ATL. Managing validation, customer relationships, cross-functional teams, and production readiness in Costa Rica.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in New Product Introduction (NPI) program management, including risk management, cross-functional team leadership, and compliance with FDA and ISO 13485 standards. Proficient in program management tools and capable of driving continuous improvement in a medical device manufacturing environment.
Highest-signal resume keywords
NPI Program ManagementIQ, OQ, PQ ValidationFDA RegulationsISO 13485 ComplianceCross-Functional Team Leadership
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Program ManagementRisk ManagementProcess ValidationManufacturing ProcessesEngineering Drawings InterpretationPFMEAControl PlansAction LogsMilestone TrackingTechnical Documentation
Soft Skills
Team LeadershipCommunicationProblem-SolvingCustomer EngagementContinuous Improvement
Tools & Technologies
Program Management ToolsRisk RegistersIntegrated Program PlansAction LogsMilestone Tracking
Certifications & Qualifications
PMP Certification
Industry Keywords
Medical Device ManufacturingGMP RequirementsCatheter ManufacturingNPI ProcessCross-Functional Alignment
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Own the full NPI program from transfer through production launch, including integrated program planning, milestone tracking, risk management, and cross-functional alignment
- Serve as the primary technical customer contact during the NPI process
- Lead IQ, OQ, and PQ execution in compliance with FDA and ISO 13485 requirements
- Align engineering, quality, operations, supply chain, and global program management teams
- Lead, develop, and inspire a team of NPI engineers
- Identify, communicate, mitigate, and escalate program risks and blockers
- Ensure production lines, operators, equipment, documentation, and quality controls are ready before production begins
- Drive lessons learned and continuous improvement after each program phase
Requirements
What you’ll need- 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
- Strong understanding of manufacturing processes; medical and catheter manufacturing experience is a significant plus
- Proficiency in program management tools, including 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
- Fluent in Spanish and English, written and verbal
- PMP certification is a plus but not required
Benefits
Comp & perks- 🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account ATL Technology Website LinkedIn All Job Openings 1001 - 5000 employees Founded 1993 💰 Private equity on 2020-02 Improving Lives through Medical Device Innovation. Engineering Manager Job not on LinkedIn 🔥 0 minutes ago 🏢🏡 San Rafael de Alajuela – Hybrid ⏰ Full Time 🟡 Mid-level 🟠 Senior 👮♀️ Software Engineering Manager 🗣️🇪🇸 Spanish Required PMP Apply Now Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
- Own the full NPI program from transfer through production launch, including integrated program planning, milestone tracking, risk management, and cross-functional alignment
- Serve as the primary technical customer contact during the NPI process
- Lead IQ, OQ, and PQ execution in compliance with FDA and ISO 13485 requirements
- Align engineering, quality, operations, supply chain, and global program management teams
- Lead, develop, and inspire a team of NPI engineers
- Identify, communicate, mitigate, and escalate program risks and blockers
- Ensure production lines, operators, equipment, documentation, and quality controls are ready before production begins
- Drive lessons learned and continuous improvement after each program phase 🎯 Requirements
- 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
- Strong understanding of manufacturing processes; medical and catheter manufacturing experience is a significant plus
- Proficiency in program management tools, including 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
- Fluent in Spanish and English, written and verbal
- PMP certification is a plus but not required Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates About us Is Remote Rocketship legit? Privacy policy Terms of service Job board SEO course Remote Job Search MasterClass AI Apply Copilot OpenClaw job finder Find jobs using your resume Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs