Manufacturing Line Lead

About Femasys

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 Line Lead 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 is responsible for supporting Manufacturing Management in the production of commercial medical devices in the clean environment rooms, through implementation of production schedule, target production rates and providing direction for production personnel.

Core Responsibilities

• Lead the production of medical devices through:

• Monitoring of production personnel to ensure compliance with standard operating procedures

• Anticipation of problems prior to production impact

• Proper response when issues are identified

• Mentor and lead manufacturing personnel through minor issues to ensure production requirements are met and provide proper feedback to Manufacturing Management

• Observe, maintain, coordinate and complete standard work

• Perform in-process and final lot acceptance activities for product

• Responsible for process documentation accuracy, completion, and transfer to appropriate personnel

• Maintain a clean and organized work area to facilitate manufacturing functions

• Identify process improvements to minimize downtime, improve yield and costs, and work to implement these improvements

• Work closely and communicate with other employees to build a cohesive production team within a dynamic, fast paced environment

• Monitor, clean, and maintain the Controlled Environment Room(s). Ensure proper and accurate inventory levels are maintained in the CERs and KanBan areas

• 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

• Support Department leadership in the performance review process by providing input and performance data for relevant employees

Supplemental Job Functions

• Accurately pull and count components for manufacturing work orders
• Deliver materials to specified work areas
• Ship and receive palletized product for further processing
• Print product labels
• Track and order supplies/materials
• Perform routine cleaning and preventative maintenance on equipment and facilities, as required

What We're Looking For

• High school diploma or equivalent
• 2 years experience as a production assembler/operator in the medical device or pharmaceutical industry
• Ability to understand and execute established written procedures is essential
• Good documentation and record keeping skills are essential
• Experience working with ISO requirements, cGMP guidelines, and FDA regulations is a plus

What We Offer

• Comprehensive health benefits (medical, dental, vision)
• 401(k) with match
• Opportunity to make a meaningful impact in women's reproductive health

Join us in shaping the future of women's health.

Visit https://femasys.com to learn more and apply today.