Position Summary: 

As a member of the Operations team, the Manufacturing Technician will be responsible for building the SoftVue system. This position will assemble product components, document production information, install software, perform cycle testing and inspection during manufacturing. The Manufacturing Technician will be responsible for building the SoftVue system according to work instructions while adhering to FDA regulations.

Primary Responsibilities:

• Build the SoftVue system by following work instructions for electronic and mechanical assemblies, device testing, cable harness assemblies, etc.
• Support manufacture of product, assuring conformance of processes with Good Manufacturing Practices (GMP) and applicable regulations and standards such as Quality System Regulations (FDA 21 CFR 820), ISO 13485
• Help with problem-solving activities and failure investigations related to manufacture, inspection, and testing, such as CAPAs, NCRs, and supplier-related issues.
• Troubleshoot and repair complicated mechanical, electrical, and plumbing problems.
• Document all work performed using CRM, ERP and QMS software.
• Achieve team objectives and remain focused on safety, quality, and timely execution.
• Work within production schedule requirements.
• Regularly keep up to date on training through the company’s Learning Management System (LMS). 

Supervisory Responsibilities:

N/A

Qualifications:

To perform this job successfully, an individual must be able to perform each primary responsibility 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.

Language Ability:

Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, suppliers, customers, and colleagues.

Math Ability:

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rates, ratios, and percentages. Ability to draw and interpret bar graphs.

Reasoning Ability:

Ability to apply principles of logical or critical thinking to a wide range of intellectual and practical problems. 

Education/Certifications:

• High School diploma or GED
• Training and certification in forklift, preferred. Applicant must be willing to receive forklift training, if hired.

Work Experience:

• At least two years’ experience as a manufacturing technician, preferred.
• Knowledge of production processes in the medical device industry, preferred.

Computer Skills:

• To perform this job successfully, an individual should have experience in the use of MS Office (Word, Excel, and PowerPoint), CRM Software, and other standard computer applications (email, web browser, etc.). 
• Understanding of and experience with ERP systems.
• Capable of identifying ways to troubleshoot software problems.

Knowledge, Skills, and other Abilities:

• Medical device design experience preferred.
• Ability to assemble and disassemble equipment and devices.
• Excellent organizational and collaborative skills.
• Good time management skills to maintain sufficient progress daily.
• Ability to communicate effectively and work in a team environment.
• Strong technical and mechanical aptitude.
• Ability to read and comprehend CAD electrical/mechanical drawings, preferred.
• Keen attention to detail and problem-solving techniques.
• Knowledge of GLP, cGMPs, ISO and ASTM standards, beneficial.
• Self-starter with a team-first mentality and a drive to succeed.
• Soldering experience, preferred.

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 regularly required to sit, use hands, and talk or hear. The employee is frequently required to stand, walk, and reach with hands and arms. The employee is occasionally required to climb or balance, and stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 50 lbs. They also occasionally move objects weighing up to 75 lbs., and sometimes, but rarely, up to 100 lbs. Specific visual abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to see color. 

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.

While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The employee is occasionally exposed to fumes or airborne particles, and risk of electrical shock. 

The noise level in the work environment is usually moderate. 

Travel:

Minimal travel