Lead Engineering Technician

Position Summary

The Lead Engineering Technician is an integral part of the R&D organization, supporting new product development, product lifecycle management, operations engineering, and laboratory excellence initiatives. This role provides technical leadership and guidance to laboratory technicians, coordinates project testing activities, and serves as a key technical resource for engineering teams. Responsibilities include planning and conducting laboratory testing, developing test methods, performing product and failure analysis, managing laboratory resources, supporting regulatory compliance, and leading continuous improvement initiatives. This position also serves as a mentor and trainer for laboratory personnel while promoting a culture of safety, quality, and operational excellence.

Essential Duties & Responsibilities
" Assists in leading and training Engineering Technicians within the R&D laboratory.
" Provides technical expertise and guidance to laboratory personnel throughout project execution.
" Supports testing prioritization and resource allocation for New Product Development and Product Engineering projects.
" Plans, coordinates, and conducts testing activities of moderate to significant complexity.
" Performs technical work requiring independent evaluation, selection, and adaptation of laboratory techniques, procedures, and criteria.
" Develops new approaches to solve non-routine technical and laboratory challenges.
" Serves as the laboratory testing representative on cross-functional project teams.
" Performs product evaluations, returned product analysis, failure investigations, and production quality assurance testing.
" Collects, analyzes, and interprets test data and prepares technical reports and recommendations.
" Reviews testing data, analyses, and reports generated by laboratory technicians.
" Develops, validates, and documents laboratory test methods and procedures.
" Creates and maintains standard laboratory test protocols and engineering records.
" Maintains laboratory notebooks and documentation in accordance with company requirements.
" Assists engineers with engineering investigations, reports, and technical studies.
" Organizes, develops, and maintains laboratory testing capabilities to support current and future project needs.
" Works with vendors, suppliers, and internal departments to resolve technical issues and coordinate project activities.
" Participates in and helps lead Lean Manufacturing and 6S initiatives within laboratory environments.
" Identifies opportunities for laboratory process improvements and drives implementation of continuous improvement activities.
" Provides budgetary input and resource recommendations to laboratory management.
" Ensures compliance with GMP, FDA, ISO, and company quality system requirements.
" Supports development and maintenance of departmental policies and procedures.
" Assists in recruiting, onboarding, developing, and mentoring laboratory personnel.
" Participates in employee performance feedback and development activities.
" Promotes and participates in Environmental, Health, and Safety (EHS) programs and initiatives.
" Assists with investigation and documentation of safety incidents and implementation of corrective actions.
" Trains technicians in laboratory testing methods, equipment operation, data collection, documentation procedures, and laboratory best practices.
" Participates in company-sponsored training and development programs related to medical device development, quality systems, and regulatory compliance.
" Plans and conducts projects of limited scope or portions of larger projects with minimal supervision.
" Performs other duties and special projects as assigned by the Laboratory Supervisor or Manager.

Knowledge & Skills
" Strong understanding of engineering principles, laboratory testing methodologies, and product evaluation techniques.
" Knowledge of medical device development processes and engineering laboratory operations.
" Experience with troubleshooting laboratory equipment, test systems, and product-related issues.
" Strong analytical, problem-solving, and technical decision-making skills.
" Ability to develop and implement testing methodologies and laboratory procedures.
" Knowledge of engineering documentation and record-keeping practices.
" Working knowledge of GMP, FDA regulations, ISO 9001, and medical device quality systems.
" Familiarity with industry standards applicable to medical devices, including IEC and related standards.
" Knowledge of Lean Manufacturing, 6S, and continuous improvement methodologies.
" Ability to communicate effectively, both verbally and in writing.
" Ability to lead, mentor, and train technical personnel.
" Proficiency in Microsoft Office applications and data analysis tools.
" Experience collecting, analyzing, and presenting technical data and test results.
" Ability to manage multiple priorities and meet project deadlines.
" Strong interpersonal skills with the ability to work effectively across multiple departments and organizational levels.

Applicants must be legally authorized to work in the United States for the anticipated duration of the assignment. Neither the client nor the supplier will provide sponsorship for an employment-based visa in connection with this assignment.

Quals--
Minimum Qualifications, Education & Experience
" Must be at least 18 years of age.
" Bachelor's Degree in Engineering or a related technical discipline with a minimum of 5 years of relevant experience; or
" Associate Degree or Technical/Vocational Certificate in a related technical field with a minimum of 10 years of progressively responsible engineering technician experience.
" Experience working within a regulated manufacturing, testing, or medical device environment preferred.
" Previous experience providing technical leadership, mentoring, or work direction to engineering technicians preferred.
Work Environment
" This position operates primarily within an engineering laboratory and office environment.
" Routinely uses laboratory equipment, testing systems, and standard office equipment.
" May occasionally work within manufacturing or production environments to support product investigations and testing activities.
" While performing the duties of this position, the employee may be required to sit, stand, walk, bend, and use laboratory equipment for extended periods.
" Must be able to occasionally move and lift objects up to 25 pounds.
" Requires adherence to all laboratory safety protocols, environmental regulations, and company policies.
" May require interaction with chemicals, electronic equipment, and test apparatus commonly used in engineering laboratories.
" Supports and promotes a safe, clean, and organized laboratory environment through active participation in safety and 6S programs.

Applicants must be legally authorized to work in the United States for the anticipated duration of the assignment. Neither the client nor the supplier will provide sponsorship for an employment-based visa in connection with this assignment.