Key responsibilities of the Lab Technician involve test and analysis utilizing a variety of engineering fixtures and machines as well as support of R&D manufacturing phase of product and operators training process. In addition, test protocol and Lab report generation will be a key deliverable for the position.
Essential Duties and Responsibilities:
• Operate process manufacturing equipment (3D printers, thermoforming, CNC, laser marking equipment, power tool) during testing.
• Calibrate laboratory equipment and log calibration dates in a regular basis or as needed.
• Document all procedures.
• Maintain and organize the Lab cabinets and equipment.
• Assist in all activities related to product development –prepare sample for testing, perform routine testing, keep lab documentation.
• Provide support to developing processes in production environment
• Support validation process IQ, OQ and PQ
• Provide training activity and share knowledge with production operators
• Help maintain good laboratory housekeeping
Critical Success Factors:
• Basic MS Office skills. Particularly Excel and Word.
• Must have excellent attention to detail as this will be a key component of data integrity, fixture set up and Protocol/ Lab report generation.
• Team player that has a history of providing assistance and technical support to production, material and service teams.
• The ability to finish quickly projects that affect NPD or International registration as these requests are time sensitive.
• Ability to work well under pressure and able to utilize problem solving techniques effectively.
• Ability to recognize, evaluate, prioritize and manage multiple activities.
• Attention to detail and precision in work.
• Ability to work effectively in a team environment.
• Ability to perform as active supervisor during transition of project to operation
• High integrity. Sometimes the test data will show design problems which could potentially delay the launch date of a project. The financial impact of a launch date delay should never be the reason that some data is removed from a Lab Report. This candidate must objectively stand by their data.
Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
• Associates Degree or equivalent formal education/training in a related field.
• A minimum 1 year of related laboratory experience including intermediate experience with dental techniques is essential. Medical device industry preferred.
• Must have the ability to perform routine sample testing
• Work effectively from prints, R&D drawings, engineering sketches and instructions
• Some machining experience is required. Ability to reed the electrical diagrams is a plus.
• Requires ability to communicate effectively orally and in writing.
• Familiarity in Outlook, Word and Excel
• Excellent attention to detail is essential.
• Knowledge of GMP practices is important
• Strong team work skills are essential.
• Good written, verbal, computer and interpersonal communication skills.
• Preferred 1 years of Lab Report writing experience required in a manufacturing environment.
• FDA and ISO 13485 experience preferred.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts such as probability and statistical inference, and ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
To perform this job successfully, an individual should have knowledge of Spreadsheet software and Word Processing software.
Physical Demands: 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.
While performing the duties of this job, the employee is occasionally required to stand; walk and sit. The employee must occasionally lift and/or move up to 10 pounds.
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.