NPI Engineer - R&D

ConvaTec Inc.; Reynosa; Presencial; MXN 600.000 - 960.000; Jornada completa

Descripción de la vacante

Convatec is seeking an NPI Engineer to lead design transfer activities for the Infusion Care product range. You will develop processes for new product development, ensure documentation meets ISO 13485 and 21 CFR 820, and drive successful design transfers from Science & Innovation to manufacturing.

The role requires 3+ years in medical device engineering, strong CAD skills (SolidWorks/AutoCAD), and fluent English.

Formación

• 3+ years in medical device engineering.
• Experience with new launch projects/products.
• Knowledge of regulatory requirements (FDA QSR/ISO 13485).
• Proficient with design transfer and cross-functional collaboration.
• Strong CAD skills and problem-solving abilities.

Responsabilidades

• Lead design transfer activities from concept to manufacturing.
• Develop processes for new product development and improve existing ones.
• Ensure documentation complies with ISO 13485 and 21 CFR 820.
• Coordinate with stakeholders and manage project priorities.

Conocimientos

Medical device experience

New product launches

Design transfer

English proficiency

Project management

CAD Software

Regulatory understanding

Educación

Engineering degree

PMP certification knowledge

Green Belt certification

Herramientas

SolidWorks

AutoCAD

Descripción del empleo

Position Overview: The New Product Introduction (NPI) Engineer is responsible for leading design transfer activities and delivering a portfolio of projects that support and sustain the Infusion Care product range, while aligning with the strategic priorities of the Infusion Care Business Unit.

Key Responsibilities

Develop processes and specifications for new product development and for improvement of existing processes/products to ensure the delivery of required documentation to allow smooth transition of processes and design from Science & Innovation (S&I) to manufacturing (Design transfer). Design and develop new materials or improve existing products / materials in accordance with customer requirements and in compliance with current regulatory requirements and standards following valid Standard Operating Procedures (SOPs) from design and Change Control Request (CCR). Lead team assignments and projects, establish strategies for their work and project execution as needed by the Project Manager or Change Control Request (CCR) owner. Evaluate requirements of new projects or resources; estimate realistic time to completion. Prioritize resource deployment in alignment with stakeholders’ priorities and overall business impacts. Develop clear and concise reporting of the team’s activities, priorities, and project statuses, and develop a cadence of regular communication to stakeholders. Ensure all required feasibility work, analysis, validation, testing, and trials are performed on time and to the required Quality and Regulatory standards, as well as in line with Convatec procedures and processes. Maintain working technical knowledge of a broad range of manufacturing processes and materials areas relevant to the Infusion Care product range. Ensure project activities (design transfer) are carried out within a Design Controls Framework in accordance with ISO 13485 & 21 CFR 820 Quality Systems. Develop and maintain strong, collaborative working relationships with all key internal and external organizational stakeholders. Corrective Actions and Preventive Actions (CAPA) relating to product design, product of packaging design changes to improve quality or reduce cost. Represent Science and Innovation (S&I) for Infusion Care in the Change Control Request (CCR), NC (Non-Conformity) / Corrective Actions and Preventive Actions (CAPA), and New Product Development (NPD) processes/transfer. Lead the Design and Development of medical devices from Concept to Launch. Direct creation of new concepts via 3D models and assemblies in CAD/CAM software (preferably Solidworks and Autocad). Resolve concept ideas to practice through prototyping and/or other rapid simulation techniques. Participate in the design and development of new products in accordance with customer request andin compliance with regulatory requirements via SOPs (e.g. Design inputs, Design output, Material/Product specifications, Product drawings, Product Verification and Validation, Test method development, shelf life, biocompatibility, design transfer, design review). Responsible for planning the order and dependencies on design control documentation according to project time plan, including transparency of completing the tasks. Participate in risk management meetings supporting the risk mitigations from product design requirements. Participate in design for manufacturing and design for assembly discussions. Participate in process development activities (DOE, ES) and support as NPI Engineer on process validations (OQ, PQ). Create the necessary documentation according to the internal systems (QMS-SAP) to be able to plan a special test run, such as Quality Alert, training, Test Order format, etc. Plan the activities required with the team (logistics, materials, purchasing, production, planning, shipping, quality, etc) to run properly in production the special test order. Ensure the successful execution of the test order by being present during production, training the personnel involved, and monitoring performance throughout the trial run to verify that all requirements and expectations specified by the requestor are met. Led the successful introduction of manufacturing equipment associated with design transfer activities. Create purchase orders, make quotations with different suppliers, when required. Energy, Environmental, Health and Safety Responsibilities (EEHS): Integrate EHS and Energy requirements into new product introductions, process implementations, and manufacturing transfers, ensuring the identification and control of risks, environmental aspects, and energy performance improvement opportunities. Coordinate and monitor compliance with applicable EHS and Energy operational controls, legal requirements, and standards throughout the NPI implementation and validation phases. Promote continuous improvement by identifying opportunities to optimize safety, environmental, performance, and energy efficiency within manufacturing processes.

Skills & Experience

• Experience working within Medical Device or equivalent regulated industry in an Engineering-biased role, as minimum 3 years’ experience. Required.
• Experience participating in new launch projects / products. Required.
• Experience working with relevant processes and technologies at core of Convatec infusion products (e.g. injection molding, adhesives, welding technologies, plastics). Required.
• Excellent communication, problem solving and analytical skills. Required.
• Strong organizational, planning and time management skills. Required.
• Act with a sense of urgency and take appropriate actions in conditions of uncertainty. Required.
• Ability to communicate effectively in English (verbal and written). Required.
• Good computer skills Microsoft Office (Outlook, Excel, Word, and PowerPoint). Required.
• ProjectManagementSkills.Required.
• Ability to understand business and operational objectives and prioritize high volume and complex workloads accordingly. Required.
• Experience with product and process validation activities. Desired.
• Experience handling software like SolidWorks, Autocad, or similar. Desired.

Qualifications/Education

• English C1. Required
• PMP knowledge, Certification is desired
• Green Belt certification is desired
• Knowledge of a New Product Development (NPD) stage gate process (IDEAL). Desired
• Knowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations. Required
• Interpretation Course in the ISO 14001 standard, Induction in Legal Requirements in Environmental Matters, Training in the documents of the Environmental System, Attention and Response to Disasters, Operational Controls that correspond to them, Determination of Significant Environmental Aspects and Impacts that correspond to them, EEHS Policy and Environmental Objectives

Travel Requirements

This role may require occasional travel. Examples include visits to manufacturers/ suppliers/ other Convatec sites or attend external training courses which may involve daytime return travel or an overnight stay. Approximately 10 to 30 days annually/ 25% of the time

Equal Opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

About Convatec

Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With over 10,000 colleagues, we provide products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention, treatment for hard to heal wounds, at-risk skin and ulcerated tissue to supporting debilitating conditions, improved patient outcomes and reduced care costs.

Convatec's revenues in 2025 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit: http://www.convatecgroup.com.

Convatec is a global medical products and technologies company focused on solutions for the management of chronic conditions, with leading market positions in advanced wound care, ostomy care, continence & critical care, and infusion care. Our products provide a range of clinical and economic benefits including infection prevention, protection of at-risk skin, improved patient outcomes and reduced total cost of care.

If you would like to know how we intend to use your data following your application please refer to our full data privacy policy on the following link: https://www.convatecgroup.com/privacy-policy/