Base Business Sr Engineer (Mexico)

Cordis; Celaya; Presencial; USD 60,000 - 100,000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Base Business Senior Engineer to oversee production products while ensuring compliance with medical regulations. This role involves evaluating product specifications, leading cross-functional projects, and providing technical expertise in design validation. The ideal candidate will possess a strong engineering background, excellent communication skills in both English and Spanish, and a proven track record in managing complex projects in a regulated environment. Join a dynamic team dedicated to innovation and excellence in medical device development, where your contributions will directly impact patient safety and product quality.

Formación

• 7+ years of experience in a regulated R&D environment.
• Fluent in English and Spanish with excellent communication skills.

Responsabilidades

• Evaluate alternatives considering cost and technical risk.
• Manage product development projects within a cross-functional team.

Conocimientos

Medical Device Design Control

Regulatory Compliance

Technical Leadership

Risk Management

Communication Skills

Strategic Thinking

Project Management

Teamwork Skills

Educación

Bachelor's Degree in Engineering

Herramientas

Microsoft Office

MRP/ERP Systems

Descripción del empleo

Las Visión de Conjunto

The Base Business Senior Engineer is responsible for all our products that are already on production. The primary responsibility of the position is to maintain our products in compliance with the existing medical regulations. Additionally, the engineer must be capable of evaluating the feasibility of any changes related to product specifications, design inputs, product design, verification testing, and supporting design validation studies.

Responsabilidades

• Evaluating alternatives considering cost, technical risk, reliability, and user needs.
• Understanding of medical device design control requirements and managing product development projects effectively within a cross-functional, multicultural, worldwide team.
• Providing technical leadership on projects and technology development efforts.
• Accountable for deliverables such as: Design History File compilation, translation/creation and documentation of requirements, ideation/prototyping, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and supporting documentation for regulatory submissions.
• Executing and documenting design and engineering changes.
• Performing design analysis, including tolerance analysis, strength of materials, risk analysis, and statistical evaluations.
• Managing, directing, and supporting suppliers involved in product development and ongoing production.
• Assisting in preparing technical brochures and acting as a technical consultant to marketing.

Calificaciones

• Bachelor's degree in Engineering (Mechanical, Biomedical, or related field).
• 7+ years of experience in a highly regulated R&D/Transfer environment on medical devices or similar.
• Excellent communication skills, both written and spoken. Fluent in English and Spanish.
• Strategic thinking and planning abilities.
• Knowledge of document control and engineering change management processes.
• Leadership skills to guide project teams towards operational goals.
• Ability to contribute to strategic goal-setting for the department or business unit.
• Extensive experience with FDA and international regulations, GMP standards, and ISO13485 is highly desirable.
• Proficiency in Microsoft Office applications; knowledge of MRPs/ERPs is a plus.
• Understanding of manufacturing methodologies, technologies, and materials used in medical devices.
• Effective teamwork skills across functions and sites.
• Ability to apply advanced technical knowledge to manage diverse projects.
• Participation in policy and procedure development to meet specific objectives.
• Recommendation of new practices, processes, or metrics.
• Experience leading complex, long-term projects with significant impact.
• Mentorship capabilities for less experienced colleagues.