Product Development Engineer
Femasys•Suwanee, GA
About The Position
Femasys is a biomedical company focused on developing and commercializing solutions for reproductive care, including technologies for permanent contraception, fertility enhancement, and diagnostic procedures. The Product Development Engineer plans, organizes, and implements the design and development of devices in Femasys’ product portfolio. This hands-on role supports medical devices from concept through market introduction and calls for initiative, ingenuity, and strong problem-solving skills.
Requirements
- Bachelor’s degree in engineering (Mechanical/Biomedical) or a related scientific field.
- At least 3 years of experience in pharmaceutical, biotech, or medical device mechanical design and/or manufacturing; alternatively, a graduate degree and at least 2 years of experience.
- Experience with SolidWorks or 3D CAD software.
- Experience communicating project concepts, ideas, and information effectively to supervisors, operators, and other team members.
- Experience with ISO 13485 and FDA design controls.
- Good verbal and written communication skills.
- Ability to prioritize in a fast-paced, changing environment.
- Comprehensive knowledge of general computer software, including word processing, spreadsheets, statistical analysis software, and project tracking software.
- Excellent time management skills and comfort working on multiple projects at once.
Responsibilities
- Ensure projects are completed on time and within budget, with priorities established and agreed upon with R&D leadership.
- Lead or support product conceptualization, planning, and design.
- Conduct risk assessments, design reviews, design verification testing, product validation, and usability testing.
- Design and develop components, products, processes, fixtures, and test systems.
- Conduct or contract testing to evaluate components, products, and processes.
- Create testing protocols, engineering specifications, drawings, technical reports, and other product documentation.
- Fabricate or oversee production of prototype and pre-clinical products, as well as fabrication of manufacturing equipment and tooling.
- Procure capital equipment and tooling.
Benefits
- Medical, dental, and vision health benefits.
- 401(k) with match.
- Opportunity to make a meaningful impact in women’s reproductive health.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
