Technician

Position Summary

The Technician plays a crucial role in the production of and process development for high-quality medical devices by operating machinery, assembling components, and adhering to strict quality and regulatory standards. Close cooperation with engineers is required. This position requires a strong commitment to precision, efficiency, and safety.

Responsibilities/Duties

•Production Operations:

o Operate and monitor production equipment in accordance with established procedures

o Assemble, inspect, and test medical devices and components to ensure compliance with specifications

o Perform packaging and labeling of finished products per company standards

•Assist Engineers:

o Work with engineers on process development, tooling and prototype builds for new products

o Develop installation and maintenance procedures for new equipment 

o Take part in Kaizen events to optimize aspects of the manufacturing processes.

o Assemble, inspect and test prototype components and products

o Perform process validation builds for special processes such as gluing and sealing

o Provide feedback to engineers, operations team members and suppliers 

•Quality Assurance:

o Conduct in-process and final inspections to identify defects or deviations

o Document production data and inspection results accurately in logs or systems

o Report any equipment malfunctions, safety concerns, or quality issues promptly

•Compliance and Safety:

o Follow Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)

o Maintain a clean, safe, and organized work environment, adhering to health and safety regulations

o Participate in required training sessions for compliance and process improvement

•Team Collaboration:

o Work closely with quality assurance, maintenance, and engineering teams to ensure seamless production

o Support continuous improvement initiatives by providing feedback and suggestions

Additional duties as required

Minimum Qualifications, Education, and Experience Required

Education & Experience

● High school diploma or equivalent required. Associates degree or equivalent in a technical subject desirable

● 3 years minimum demonstrated experience in assembly. Experience with small medical devices is preferred

● Basic understanding of GMP, ISO standards, or FDA regulations

● Strong attention to detail and ability to follow precise instructions

● Problem solving skills and ability to troubleshoot

● Excellent manual dexterity and hand-eye coordination

Abilities

• Ability to work in a fast-paced environment and meet production deadlines

• Ability to set up and operate machinery, develop work instructions, use mechanical and electrical tools and instruments, and to read blueprints

● Process-orientated mindset with strong communication and presentation skills, persistence and discipline, and a drive for results

● Basic computer skills including Microsoft Word and Excel

● Must possess excellent organizational, problem-solving, analytical, interpersonal, and communication skills

● Self-starter, ability to prioritize work and work independently

● Ability to use equipment such as a microscope, soldering iron, cutters, and various hand tools.

Work Conditions:

Work is performed primarily in a manufacturing environment.  Essential functions require sufficient physical ability and mobility; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push/pull up to 40 pounds; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard).  Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).