{"id":2753290,"url":"https://alion.io/job/convatec-npi-engineer-rd","title":"NPI Engineer - R&D","company":{"id":1845197,"name":"Convatec","domain":"convatec.com","url":"https://alion.io/company/convatec-com","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":83,"open_postings":9,"ghost_share":0,"stale_share":0.667,"repost_share":0,"time_to_fill_p50_days":29,"computed_at":"2026-10-17T05:46:00Z"}},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"middle","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Reynosa, Mexico"],"countries":["MX"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":22000,"max_usd":54000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":10},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AutoCAD","optional":false},{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-10-15T00:00:00Z","employer_posted_date":"2026-10-15","last_verified_at":"2026-10-17T05:43:13Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"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.\nKey Responsibilities:\nDevelop 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).\nDesign 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).\nLead team assignments and projects, establish strategies for their work and project execution as needed by the Project Manager or Change Control Request (CCR) owner.\nEvaluate requirements of new projects or resources; estimate realistic time to completion.\nPrioritize resource deployment in alignment with stakeholders’ priorities and overall business impacts.\nDevelop clear and concise reporting of the team’s activities, priorities, and project statuses, and develop a cadence of regular communication to stakeholders.\nEnsure 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.\nMaintain working technical knowledge of a broad range of manufacturing processes and materials areas relevant to the Infusion Care product range.\nEnsure project activities (design transfer) are carried out within a Design Controls Framework in accordance with ISO 13485 & 21 CFR 820 Quality Systems.\nDevelop and maintain strong, collaborative working relationships with all key internal and external organizational stakeholders.\nCorrective Actions and Preventive Actions (CAPA) relating to product design, product of packaging design changes to improve quality or reduce cost.\nRepresent 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.\nLead the Design and Development of medical devices from Concept to Launch.\nDirect creation of new concepts via 3D models and assemblies in CAD/CAM software (preferably Solidworks and Autocad).\nResolve concept ideas to practice through prototyping and/or other rapid simulation techniques. \nParticipate 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).\nResponsible for planning the order and dependencies on design control documentation according to project time plan, including transparency of completing the tasks.\nParticipate in risk management meetings supporting the risk mitigations from product design requirements.\nParticipate in design for manufacturing and design for assembly discussions.\nParticipate in process development activities (DOE, ES) and support as NPI Engineer on process validations (OQ, PQ).\nCreate 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.\nPlan the activities required with the team (logistics, materials, purchasing, production, planning, shipping, quality, etc) to run properly in production the special test order.\nEnsure 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.\nLed the successful introduction of manufacturing equipment associated with design transfer activities.\nCreate purchase orders, make quotations with different suppliers, when required.\nEnergy, 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.\nSkills & Experience:\nExperience working within Medical Device or equivalent regulated industry in an Engineering-biased role, as minimum 3 years’ experience. Required.\nExperience participating in new launch projects / products. Required.\nExperience working with relevant processes and technologies at core of Convatec infusion products (e.g. injection molding, adhesives, welding technologies, plastics). Required.\nExcellent communication, problem solving and analytical skills. Required.\nStrong organizational, planning and time management skills. Required.\nAct with a sense of urgency and take appropriate actions in conditions of uncertainty. Required.\nAbility to communicate effectively in English (verbal and written). Required.\nGood computer skills Microsoft Office (Outlook, Excel, Word, and PowerPoint). Required.\nProjectManagementSkills.Required.\nAbility to understand business and operational objectives and prioritize high volume and complex workloads accordingly. Required.\nExperience with product and process validation activities. Desired.\nExperience handling software like SolidWorks, Autocad, or similar. Desired.\nQualifications/Education:\nEnglish C1. Required\nPMP knowledge, Certification is desired.\nGreen Belt certification is desired.\nKnowledge of a New Product Development (NPD) stage gate process (IDEAL). Desired.\nKnowledge of requirements of FDA's QSR, GMP and ISO 13485 or similar regulations. Required.\nInterpretation 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\nTravel Requirements:\nThis 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\nReady to join us?\nAt Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.\nBeware of scams online or from individuals claiming to represent Convatec\nA formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.\nIf you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If you’re unsure, please contact us at .\nEqual opportunities\nConvatec 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.\nNotice to Agency and Search Firm Representatives\nConvatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.\nAlready a Convatec employee?\nIf you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View \"Convatec Internal Career Site - Find Jobs\". Thank you!\nAbout Convatec\nPioneering trusted medical solutions to improve the lives we touch:\nConvatec 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). 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