Sr. Engineer I - Validation

Job Summary

The Senior Validation Engineer I position is responsible for providing technical expertise, leadership and planning for manufacturing process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment/process validation requirements.  The Senior Validation Engineer I uses their breadth of process and validation engineering knowledge and product development experiences to serve as a process validation leader providing process validation guidance, oversight and coaching to other engineers.  The Senior Validation Engineer I position is specifically accountable for leading process validation activities to ensure the transferred process is successfully implemented and completed in accordance within all TMC processes and procedures.

Job Details/Responsibilities

• Adhere to TMC Quality System requirements, including but not limited to change management, design controls, risk management, process validation and good documentation practices.
• Provide technical leadership in planning and executing projects related to the development, installation, and qualification of new products, equipment, or processes. Support continuous improvement and optimization of existing manufacturing processes in alignment with business objectives.
• Design and implement strategies for process characterization, equipment and process validation and qualification. Ensure thorough documentation and compliance during the introduction of new, improved, or transferred processes into full-scale manufacturing.
• Plan and manage project timelines, budgets, and resources. Prepare regular reports and ensure effective communication of project status, risks, and outcomes to stakeholders.
• Assign and oversee validation tasks for junior engineers, providing guidance and support to ensure successful project execution and professional development.
• Lead cross-functional teams in the implementation of new or modified equipment, products, or processes. Represent the Validation Engineering function in performance improvement meetings, contributing ideas and methodologies to enhance department and company performance.
• Provide support for in-process Test Method development and Test method validation activities
• Provide support for internal and external audit as Validation Engineering SME

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Strong understanding of FDA regulations, ISO 13485, GMP, and other relevant quality and compliance standards
• In-depth knowledge of process validation, equipment qualification (IQ/OQ/PQ), and software validation.
• Strong familiarity with quality management systems (QMS), including change management, design controls, CAPA, risk management, and document control.
• Solid grounding in mechanical, chemical, or biomedical engineering principles.
• Understanding of statistical tools and techniques (e.g., DOE, SPC, Gage R&R) for process analysis and validation.
• Experience with running process characterization studies, executing protocols, and completing technical reports. 
• Experience in the application of Design for Six Sigma (DFSS), Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.  
• Knowledge of product development processes, including design control and technology transfer.
• Ability to write clear, concise, and compliant validation protocols, reports, and technical documentation.
• Skilled in planning, executing, and managing multiple validation projects simultaneously.
• Strong analytical and troubleshooting skills to identify root causes and implement effective solutions.
• Proficiency in analyzing validation and process data using tools like Minitab, Excel, or JMP.
• Effective verbal and written communication skills for cross-functional collaboration and stakeholder engagement.
• Ability to lead validation efforts and mentor junior engineers or technicians.
• Ability to maintain high accuracy and thoroughness in documentation and execution of validation activities.
• Comfortable working in a dynamic environment with shifting priorities and evolving technologies.
• Capable of making sound technical decisions under pressure and with limited information.
• Ability to work effectively in cross-functional teams including R&D, Quality, Manufacturing, and Regulatory Affairs.
• Strong organizational skills to meet deadlines and manage competing priorities.

Qualifications/ Background Experiences

• BS in Engineering, Material Science or related field. Advanced degree (MS) is preferred with at least 6 years of increasing responsibility and experience in Medical Device, Pharmaceutical or highly regulated industry. 
• Experience in a manufacturing environment for designing, specifying, assembling, and validating manufacturing equipment and processes.
• Experience in catheter manufacturing processes and/or catheter prototyping is preferred. Additional experience in manufacturing processes for other types of medical devices a plus.
• Six Sigma Black Belt certification is desirable