Manufacturing Technician

Femasys•Suwanee, GA

66d•Onsite

About The Position

Femasys is a pioneering biomedical company focused on advancing women's health by developing and commercializing innovative, accessible solutions for reproductive care. Our product portfolio includes breakthrough technologies for permanent contraception, fertility enhancement, and diagnostic procedures — providing meaningful options for both patients and healthcare providers. Position Summary We are looking for a Manufacturing Technician who thrives in a small, fast-paced environment and wants to play a hands-on role in bringing innovative medical devices from concept to market. This position works along side the production associates verifying processes are setup correctly and ensuring the associates are following the work instructions. The technician will work with the production team to train associates and improve manufacturing processes by eliminating opportunities for defects.

Requirements

Associate degree in a technical area is required.
High school diploma or equivalent with relevant work experience, may be acceptable.
Ability to understand and execute established written procedures.
Good documentation and record keeping skills.
Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.
You may be required to provide verification of latest eye exam.
Good manual dexterity.
Ability to sit for extended periods during the shift.
Ability to lift up to 40 lbs.

Nice To Haves

2 years experience as a Production or Engineering Technician in the medical device, pharmaceutical or other regulated industry, is preferred.
Experience working with ISO requirements, cGMP guidelines, and FDA regulations is a plus.

Responsibilities

Learn all process operations and become the technical expert.
Train Production Associates and monitor their work to ensure product is being made correctly.
Identify process issues and implement changes to reduce or eliminate any opportunities for rejects or lost efficiency.
Perform equipment setup and minor maintenance activities for equipment in production areas.
Assist supervisors/engineering on lean process improvement, lean waste reduction and other tasks related to manufacturing activities and support activities to improve reducing waste.
Support Supervisors/Engineers and obtaining production output goals.
Assemble medical devices in a controlled environment in accordance with detailed assembly instructions, processes and procedures.
Excellent dexterity and fine motor skills to work on small parts and intricate assemblies, including the use of small hand tools.
Ability to perform assembly work utilizing microscope or magnification.
Confident in operating large and small pieces of semi-automated and automated equipment.
Follow documented policies and procedures as designated by the company’s Quality System.
Observe, maintain, coordinate and complete standard work.
Perform in-process and final lot acceptance activities for product.
Complete required documentation (batch records; equipment, inspection, and test forms; labeling forms) relating to business or regulatory requirements.
Detail oriented ensuring all written documentation is complete, legible, and accurate.
Ensure all production data entered in the eERP is accurate and complete.
Assist engineering in development of equipment operation and preventive maintenance instructions.
Maintain a clean and organized work area to facilitate manufacturing functions.
Complete quality work at acceptable department/ production determined rates.
Work closely and communicate with other employees to build a cohesive production team within a dynamic, fast paced environment.
Communicate with supervisors/engineering on product performance, functionality issues and procedure updates.
Understand and perform basic calculations.
Competent working with computers and portable electronic devices.
Comfortable accessing documents and information in both the eQMS and eERP systems.
Any and all additional tasks which are assigned by your manager.
Accurately pull and count components for manufacturing work orders.
Deliver materials to specified work areas.
Ship and receive palletized product for further processing.
Print and design product labels.
Monitor, clean, and maintain the Controlled Environment Room(s).
Maintain training records within compliance.