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Senior Product Development Engineer

Femasys Inc

Suwanee, GA

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JOB DETAILS
SKILLS
Biomedical Engineering, Catheterization, Communication Skills, Document Management, Extrusion, FDA (Food and Drug Administration), FDA Requirements, ISO (International Organization for Standardization), Identify Issues, Manufacturing, Mechanical Engineering, Medical Disposables, Medical Equipment, Problem Solving Skills, Process Validation, Product Development, Product Engineering, Prototyping, Regulations, Small Company, SolidWorks, Startup, Team Player, Test Design, Test Plan/Schedule, Testing
LOCATION
Suwanee, GA
POSTED
30+ days ago

We are looking for a Senior 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 is not a narrowly defined role-you will be expected to take ownership, operate across design, testing, and development activities, and directly influence product and process outcomes.

Key Responsibilities:

  • Lead product development efforts from early concept through commercialization with a strong focus on execution.
  • Design and iterate components and assemblies using SolidWorks with minimal oversight.
  • Develop, build, and troubleshoot prototypes and test setups in a hands-on manner.
  • Design and qualify equipment (IQ/OQ/PQ) to support both development and early manufacturing.
  • Work closely with Manufacturing, Quality, and Regulatory to ensure practical, compliant solutions.
  • Identify issues quickly and drive resolution without relying on large support teams.
  • Generate and maintain design control documentation in alignment with FDA and ISO requirements.
  • Support design transfer and early production, including time on the manufacturing floor.

What We're Looking For:

  • An engineer who is comfortable operating with limited structure and high ownership.
  • A practical problem-solver who can balance speed with quality and compliance.
  • A team player who communicates directly and effectively in a small group setting.

Qualifications:

  • Bachelor's or Master's degree in Mechanical Engineering, Biomedical Engineering, or similar.
  • 5+ years of product development experience, ideally in the medical device industry.
  • Strong proficiency in SolidWorks.
  • Experience with equipment design and qualification (IQ/OQ/PQ).
  • Working knowledge of design controls and FDA/ISO 13485 requirements.
  • Demonstrated success in a small company, startup, or similar resource-constrained environment.

Preferred Experience:

  • Experience with catheter-based or minimally invasive devices.
  • Familiarity with processes such as extrusion, bonding, and assembly of disposable medical devices.
  • Experience supporting early manufacturing scale-up.

About the Company

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Femasys Inc