STAFF PRODUCT LIFECYCLE ENGINEER (MEDICAL DEVICES | BILINGUAL)

Staff Product Lifecycle Engineer (Medical Devices | Bilingual)

Location: Ciudad Juarez, Chihuahua, Mexico.

The Staff Lifecycle Engineer serves as a technical leader responsible for driving product lifecycle initiatives, design changes, and continuous product improvements for medical devices.

Key Responsibilities

• Lead projects focused on reducing design-related product variation and positively influencing company business metrics.
• Ensure projects are well scoped, follow the PE process, and meet timely progress milestones.
• Apply Project Management Mastery principles to identify risks, issues, and scope changes.
• Maintain active project plans for significant projects throughout the year, including design changes and cost improvement projects.
• Conduct regular project reviews with team and management and drive adherence to schedules.
• Identify, plan, and execute cost improvement projects supporting supply chain objectives.
• Maintain supply chain continuity by qualifying and validating supplier tooling per component approval procedures.
• Ensure closure of component non-conformance issues with timely corrective action, suppliers’ control plans, NCRs, and CAPAs.
• Follow the Design Variability Roadmap (DMAIIC) in project execution.
• Act as Development Engineer for component or equipment change coordination, development, validation, and new product stabilization.
• Maintain alignment and communication between stakeholders.
• Manage project spending to meet forecasted budgets.
• Keep technical expertise and familiarity with engineering, statistical, and predictive computer-based tools.
• Communicate business-related issues or opportunities to the next management level.
• Follow all company guidelines related to Health, Safety, and Environmental practices.
• Ensure subordinates follow all company safety guidelines and have necessary resources.
• Ensure personal and company compliance with all federal, state, local, and company regulations, policies, and procedures.
• Perform other duties as assigned.

Qualifications & Requirements

• Bachelor's Degree in Engineering or equivalent.
• 6-8 years of related engineering experience.
• Strong knowledge and skills to perform the responsibilities of the position.
• Advanced English proficiency (written and spoken); Spanish preferred.
• Proven ability to work cross-functionally and collaborate with multiple functional groups.
• Strong verbal, written, presentation, and communication skills.
• Strong project management skills with the ability to lead diverse teams and execute projects across multiple locations.
• Technical leadership and influence on stakeholders without direct authority.
• Experience managing multiple projects and priorities simultaneously.
• Manufacturing & Product Engineering experience.
• Experience with Plastic Injection Molding, Metal Injection Molding (MIM), Metal Stamping and Forming, Machining, Casting, and/or Electronic PCBAs.
• Knowledge and experience with Design for Manufacturing & Assembly (DFMA), Design for Six Sigma, Process Six Sigma, Design of Experiments (DOE), problem‑solving methodologies, risk analysis (DFMEA, PFMEA, AFMEA), statistical analysis (SPC, GR&R, ANOVA, regression, capability analysis), geometric dimensioning & tolerancing (GD&T), tooling methodologies, assembly process and equipment development, metrology and gage development, and general design engineering principles.
• Product Lifecycle & Validation experience with product design and development, design change management, product lifecycle management, CAPA and NCR management, supplier collaboration and technical support, manufacturing transfers, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
• Technical tools experience using statistical analysis software, CAD/Solid modeling software, FEA, tolerance stack-up analysis, and Microsoft Office applications including Excel, Word, and PowerPoint.

Preferred Experience & Skills

• Medical device manufacturing experience.
• Background in quality systems and regulatory environments.
• Supplier qualification and validation activities.
• Key competencies: Technical leadership, project execution, design change management, problem solving, cross‑functional collaboration, stakeholder influence, decision making, continuous improvement, portfolio management, strong business and technical communication.
• Preferred skills: Bioinformatics, biological engineering, biostatistics, coaching, critical thinking, design of experiments (DOE), healthcare trends, industry analysis, innovation, medicines and device development and regulation, product development, relationship building, research and development, SAP product lifecycle management, standard scientific processes and procedures, and technology savvy.