Product Development Engineer

Suwanee, Georgia

6 days ago

Job Description

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 Product Development Engineer 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 the planning, organization, and implementation of the design and development of devices within Femasys’ product portfolio. This role requires initiative, originality, ingenuity, and excellent problem-solving skills.

Core Responsibilities:

Ensure the timely completion and budget of projects with priorities established and agreed upon with R&D leadership
Lead or support the following product development activities:
- Conceptualization, planning, and design of new products
- Risk assessment
- Prototype design and testing
- Design reviews
- Design verification testing
- Product validation and usability testing

Designs/develops components, products, processes, fixtures, and test systems
Conducts and/or contracts testing to evaluate components, products, and processes
Creates testing protocols, engineering specifications, drawings, technical reports, and other product documentation
Fabricates or oversees production of prototype product, pre-clinical product, and manufacturing equipment/ tooling fabrication
Procurement of capital equipment and tooling

What We’re Looking For:

Required:

Bachelor’s degree in engineering (Mechanical/ Biomedical) or related scientific field
3+ years (or graduate degree and 2+ years) of experience in pharmaceutical, biotech, or medical device mechanical design and/or manufacturing
Experience with SolidWorks or 3D CAD software
Experience effectively communicating project concepts, ideas, and information
to supervisors, operators, and other team members
Experience with ISO 13485, FDA design controls
Good verbal and written communication skills
Ability to prioritize in a fast-paced, changing environment
Comprehensive knowledge of general computer software that includes word processing,
spreadsheets, statistical analysis software, and project tracking software
Excellent time management skills and comfortable working on multiple projects at once

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.
Apply now at

HR@femasys.com

or visit https://femasys.com to learn more.

Numbers & Facts

Location	Suwanee, Georgia
Website	https://www.femasys.com/careers

Skills

Biomedicineunmatched
Biotech and Pharmaceuticalunmatched
Budgetingunmatched
CAD (Computer-Aided Design) Softwareunmatched
Capital Equipment Purchasingunmatched
Communication Skillsunmatched
Computer Softwareunmatched
Contract Analysisunmatched
Design Verificationunmatched
Engineering Drawingunmatched
Establish Prioritiesunmatched
FDA (Food and Drug Administration)unmatched
Family Planningunmatched
Healthcare Providersunmatched
ISO (International Organization for Standardization)unmatched
Leadershipunmatched
Machine Toolunmatched
Manufacturingunmatched
Manufacturing Equipmentunmatched
Mechanical Designunmatched
Mechanical Engineeringunmatched
Medical Equipmentunmatched
Medical Productsunmatched
Multitaskingunmatched
Pre-Clinicalunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Product Designunmatched
Product Developmentunmatched
Product Documentationunmatched
Product Engineeringunmatched
Product Supportunmatched
Product Testingunmatched
Production Controlunmatched
Project Trackingunmatched
Prototypingunmatched
Research & Development (R&D)unmatched
Risk Analysisunmatched
SolidWorksunmatched
Spreadsheetsunmatched
Statistical Analysis System (SAS)unmatched
Statistics Softwareunmatched
Technical Drawingunmatched
Test Designunmatched
Test Fixturesunmatched
Test Plan/Scheduleunmatched
Testingunmatched
Time Managementunmatched
Tool and Die Manufacturingunmatched
Usability Testingunmatched
Women's Healthunmatched
Word Processingunmatched
Writing Skillsunmatched

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Product Development Engineer

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