Product Development Engineer

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.