Development Engineer B

Description

Summary: This Development Engineer B leads biomedical textile product development and continuous improvement projects, combining technical knowledge with project leadership. Highlights: 1. Lead innovation and New Product Introduction (NPI) projects. 2. Drive continuous improvement initiatives and optimize processes. 3. Utilize data-driven problem-solving in a regulated industry. **Vacancy Name** Development Engineer B **Location of Work** Tijuana, Mexico **Employment Type** Full Time Employee **Job Description** The Development Engineer leads Biomedical Textiles product development and continuous improvement projects. This role combines strong technical knowledge with project leadership skills to develop new products and optimize manufacturing processes that meet safety, quality, cost and delivery objectives. The position utilizes cross\-functional collaboration and data\-driven problem\-solving to deliver innovative products and efficient manufacturing solutions. **Level B – Intermediate Development Engineer** * Leads innovation and New Product Introduction (NPI) projects as part of the Biomedical Textile Product Development team. * Responsible for project scope, risk management, detailed project planning, resource coordination, and on\-time delivery of project milestones and product launches. * Coordinates pilot builds, engineering runs and critical implementation activities to ensure robust process capability and operational readiness. * Leads validation of processes and equipment, ensuring compliance with internal standards and external regulatory requirements. * Leads continuous improvement initiatives to reduce scrap, optimize cycle time, eliminate waste, and increase overall product profitability (Kaizen, 5S, SMED, etc.). * Applies structured, data\-driven problem\-solving methodologies (RCA, FMEA, DMAIC, 8D) to identify root causes and deliver measurable, sustainable operational improvements. * Ensures effective communication and cross\-functional coordination with the Global Biomedical Textile team and local departments (Engineering, Production, Quality, Maintenance, Supply Chain) to align priorities and execution.Documents technical data into structured reports and presentations, effectively communicating results to cross\-functional stakeholders. **Level B – Intermediate Development Engineer** * Industrial, Manufacturing, Mechatronics, Biomedical Engineering or similar * 2\-5 years in regulated manufacturing (ideally medical ISO 13485 and FDA 820 experience) * Intermediate knowledge of statistics, Lean/Six Sigma, PFMEA, validations (IQ/OQ/PQ) * Advanced English proficiency, reading, writing and verbal (essential). * Strong communication skills to influence stakeholders, coordinate project teams and drive sustainable operational improvements. * Intermediate Project management skills, including knowledge of Stage\-Gate methodology, risk management, and cross\-functional coordination for product launches and process improvements. * Experience in manufacturing processes, engineering principles and product development in a regulated industry (R\&D/NPI) * Proficient in Lean Manufacturing and continuous improvement principles (Kaizen, 5S, SMED) with structured problem\-solving (RCA, FMEA, DMAIC, 8D) * Occasional travel may be required based on project needs. Work is primarily sedentary in nature, with occasional activities such as walking through manufacturing areas, reviewing workstations, and conducting process observations. This role may require standing for moderate periods during audits or production floor visits, as well as lifting light objects occasionally. No significant repetitive motion or strenuous physical effort is expected.