Sustaining Center Mechanical Engineer

Sustaining Center Mechanical Engineer

At our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments, manufacturing essential components such as hemodialysis disposables, peritoneal dialysis disposables, hemodialysis machines, and PD cycler machines.

The role focuses on deep mechanical engineering expertise combined with a broad understanding of sustaining project management processes. It manages product changes at all levels, refurbishment programs, and hardware configuration management in full compliance with FDA, ISO, and internal quality system requirements.

Responsibilities

• Leads sustaining changes and understands their impact on the serial production process and the necessity to provide support as needed (focus is on changes of production process triggered by design changes or vice versa).
• Conduct device functional testing and troubleshooting (mechanical and basic electronic level).
• Provide hands-on support including soldering and hardware rework when required.
• Support development and execution of refurbishment and rework programs.
• Assesses impact of design changes on serial production processes and documentation.
• Maintains hardware configuration management including BOMs, drawings, specifications, and SAP master data updates.
• Develops and/or validates engineering test methods applicable to product changes and sustaining activities.
• Creates, optimizes, and drives structured schedules and project plans. Sets and meets deadlines with quality deliverables, effectively adapting and modifying plans based on changing conditions or data.
• As cross-functional team member collaborates across all functional areas - R&D, M&SC, Product Management, QA/QC, Regulatory, Design Quality Assurance, Procurement, Clinical Operations, Service Operation and others - necessary to ensure successful project completion and delivery.
• Plans resource requirements and negotiate core team resources with R&D functional managers; assists core team members in negotiating extended team staffing of sustaining projects.
• Conducts research and development activities in compliance with GMP and FDA regulatory guidelines.
• Conducts device, electrical and hardware functional testing.
• Conducts root cause investigations related to production, field returns, and quality issues.
• Develops prototypes by researching different technologies, materials, design, and is responsible for developing testing and inspection criteria.
• Coordinates design verification testing and validation of the product hardware and structures the results to be presented to the management.
• Develops and executes hardware design verification protocols including final reports and validation.
• Coordinates and executes change controls (CR/CN) and design control processes within and between facilities and corporate level.
• Determines and evaluates product design-patentability, manufacture-ability, and patient-safety.
• Facilitates product design, researches in patent, validation, plastic material specification and functionality in accordance to the latest applicable standards.
• Supports new products regulatory registration, 510(k), NDA, HDE, IDE, CE marks, biocompatibility, etc.
• Supports work instruction (module) creation with manufacturing for product/project implementation.
• Writes CCNs to upload SOP’s, specifications, drawings, Engineering BOMs (to prepare MBOM/SAP transactions).
• Facilitates project status within the defined reporting structure. Contributes to or provides project status reports in written form, and escalations to stakeholders and management, also in English.
• Provides support to Production Department during implementations of new products and regular production.
• Functions as key player for product cost-down development and registration in International Markets and sustaining innovation and business development in support of product leader.
• Manages and implements all level complexity changes to existing and in-market products.
• Develops and/or validates engineering test methods applicable to specific product changes, fixtures and/or processes.
• Supports/leads the development of electrical hardware pFMEAs and dFMEAs.
• Supports the development activities for the Risk Management Phases during the design control process such as risk review meetings.
• Generates deviation notices (DN) for project related activities lead by the Engineering group.
• Leads technical assessments for replacement parts due to End of Life/Obsolescence issues.
• Conducts Technical reviews with cross functional teams to assess/qualify new components and changes to designs.
• Experienced and able to work with external labs such as UL, TUV for design certification purposes.
• Experienced with FPGA and CPLD programming techniques.
• Good understanding of Design for Electromagnetic Compatibility and EMI/EMC testing.
• Complies with the Code of Business Conduct and all applicable company policies, FDA QSR, ISO 13485, and regulatory requirements.

Qualifications

• BS degree or Engineering in fields of Mechanical Engineering is required. Electromechanical or Mechatronics background preferred. Master’s degree is preferred or in process.
• At least 2 years in medical device industry is preferred.
• 2–5 years of related experience in sustaining engineering, manufacturing engineering, or technical investigations preferred.
• Experience with CAPA systems, quality management systems, engineering change management (CR/CN), and hardware configuration control preferred.
• Effective written and oral communication skills in English and Spanish.
• Ability to prioritize and manage multiple tasks.
• Hands‑on troubleshooting capability including soldering skills (through‑hole and basic SMT preferred).
• Must be proficient in the use of Project management tools to develop schedules, allocate resources, and track progress.
• Basic knowledge of Hemodialysis machines is preferred.
• Knowledge of manufacturing processes (molding, automation, assembly of active medical devices as well as the design and development process (FDA compliant) for medical devices is preferred.
• Knowledge and experience of ISO, CE and TUV certification is preferred.
• Knowledge and experience with electronic hardware design tools such as SPICE and electronic board layout tools such as OrCAD is required.
• Knowledge of design of experiment, statistical skills, and Mini-Tab is preferred.
• Knowledge of basic plastic property and project management tools.
• Basic Knowledge of embedded programming (C, C++ etc.).
• Ability to prioritize and work with multiple low to medium priority projects, concurrently.
• Availability to work closely under guidance of U.S. / Germany (intercultural global collaboration).
• Stress resistant ("Firebrigade" when it comes e.g. to production stop due to quality issues).
• Talent to lead and manage people indirectly. Ability to manage through influencing others.
• Intercultural awareness and ability to work within an international environment within globally distributed teams.
• Excellent communication and written skills required. Ability to condense complex information to a understandable level, to push decisions if needed.
• Availability for Conferences with U.S. and Germany (time difference).

Our Offer for You

• You help make better medicine available to more people worldwide.
• Individual opportunities for self‑determined career planning and professional development.
• A corporate culture that encourages innovative thinking—finding the best solution together, not just the fastest one.
• A team of committed professionals with diverse skills, talents, and experiences.
• The strength of a successful global corporation combined with the collegial culture of a mid‑sized company.