Validation Engineer

The Validation Engineer at Sim Surgical will be instrumental in ensuring our devices meet all regulatory standards and company requirements. This role will design, execute, and document validation processes to support the development and manufacturing of products such as spinal implants, medical screws, and surgical tools. The role will be critical in maintaining our commitment to delivering safe, reliable, and high-quality medical devices that improve patient outcomes.

Responsibilities:

• Develop and implement validation plans for new and existing products, considering design, manufacturing processes, equipment, and software in compliance with FDA regulations and ISO standards.
• Coordinate with Engineering, manufacturing, and quality teams to establish requirements and standards for validation activities.
• Execute validation tests including but not limited to design validation, process validation, software validation, and test method validation.
• Prepare, review, and approve validation documents, including protocols, reports, and risk assessments.
• Ensure that all validation activities are conducted in accordance with internal procedures and regulatory requirements.
• Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• Provide technical support for troubleshooting and resolving validation issues encountered during production or testing.
• Stay current with industry standards, regulatory requirements, and advancements in technology and apply them to validation practices.
• Collaborate with cross-functional teams to facilitate changes or improvements in manufacturing processes, product design, and quality assurance methods.
• Assist in the development and implementation of training programs related to validation processes and procedures.

Requirements:

• Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
• Minimum of 3 years of experience in validation engineering within the medical device industry.
• In-depth knowledge of FDA regulations, including QSR and ISO 13485, as well as other international standards relevant to medical device manufacturing.
• Strong understanding of validation principles, including design, process, and software validation.
• Experience with statistical analysis tools and methodologies.
• Excellent problem-solving, analytical, and organizational skills.
• Strong communication and teamwork skills, with the ability to work effectively in cross-functional teams.
• Ability to manage multiple projects simultaneously and meet deadlines.

Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Moderate noise levels typical of a manufacturing setting.
• Regular requirement to sit, talk, and hear.
• Frequent need to walk; use hands for fine manipulation, handle objects, and reach.
• Occasional requirement to stand, climb, balance, stoop, kneel, crouch, or crawl.
• Occasionally lift and/or move objects up to 25 pounds.
• Increased time spent in an office setting for data analysis, meetings, and administrative tasks.
• Frequent use of computers and office equipment.
• Potential travel to other company locations, suppliers, customers, or industry events.