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.  As an additional, must be capable to evaluate feasibility for any change on: product specifications, design inputs, product design, verification testing and supporting design validation studies.

• Evaluating alternatives with consideration for cost, technical risk, reliability and user needs.
• Full understanding of medical device design control requirements and be able to effectively manage a product development project and work effectively in a cross functional, multi-cultural worldwide team.
• Provide technical leadership on projects and/or technology development efforts.
• Accountable for deliverables such as: Design History File compilation, translation / creation and documenting of requirements, ideation / prototyping, technical risk mitigation, verification testing and reports, design validation studies, risk management documentation, design reviews, and to support the compilation of documentation to enable regulatory submissions.
• Executes and documents design and engineering changes.
• Direct or perform design analysis, such as tolerance, strength of materials, risk analysis, and statistical evaluations.
• Manage, direct, and support suppliers involved in product development and ongoing production.
• Help prepare, and acts as a consultant to, marketing on technical brochures.

• Bachelors degree in Engineering (Mechanical, Biomedical or related field required).
• 7+ years work experience within a highly regulated R&D/Transfer environment on medical devices or similar.
• Good communication skills, written and spoken. Fluent proficiency in English & Spanish is a must.
• Strategic thinking and planning.
• Understands document control and engineering change management processes.
• Ability to lead a project team towards operational objectives.
• Aptitude to contribute to strategic goal-setting for department/business unit.
• Must have extensive working knowledge of, and experience in applying / developing products in compliance with FDA and international requirements and regulations, including GMP and other standards as they relate to the design and manufacture of medical devices. ISO13485 is highly desired.
• Proficient in Microsoft Windows Office applications. Knowledge of other applications such as MRPs/ERPs is desirable
• Knowledge of common manufacturing methodologies, technologies, and materials, such as; common materials employed in medical devices, and other manufacturing processes.
• Effectively work with others. Works well within cross-functional teams and across multiple sites, as applicable.
• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
• Participates in the development of policies and procedures to achieve specific goals.
• Recommends new practices, processes, metrics, or models.
• Works on or may lead complex projects of large scope.
• Projects may have significant and long-term impact.
• Acts as a mentor to less experienced colleagues.