Product Development Engineer

Femasys Inc.
North Atlanta, GA
Product Development Engineer Location North Atlanta, GA :

About Us

Femasys is a pioneering medical device company advancing women's healthcare through proprietary, accessible, and non-surgical technologies. Our mission is to provide innovative solutions that address significant unmet needs, empowering women and improving healthcare outcomes. As we continue to expand, we are seeking a product development engineer to help drive our product development efforts and ensure excellence in execution.

Key Responsibilities:

  • Lead and support product development activities across all phases of the product lifecycle - concept, prototyping, design verification/validation, and transfer to manufacturing.
  • Design, develop, and refine components, assemblies, and systems for medical devices in compliance with FDA and ISO standards.
  • Conduct and document risk assessments, design reviews, and root cause analyses.
  • Create detailed engineering documentation including CAD models, drawings, BOMs, and technical reports.
  • Collaborate with cross-functional teams (Quality, Regulatory, Clinical, Manufacturing) to ensure design inputs and outputs are fully aligned.
  • Participate in design verification and validation testing, including writing protocols, executing tests, and analyzing data.
  • Interface with vendors and contract manufacturers to support prototyping and production.
  • Ensure design activities meet all applicable regulatory, safety, and quality requirements.

Qualifications:

  • Bachelor's degree in mechanical engineering, biomedical engineering, or a related field.
  • 3+ years of relevant experience in product development within the medical device industry (Class II/III devices preferred).
  • Proficiency in 3D CAD (e.g., SolidWorks) and engineering drawing standards.
  • Strong understanding of medical device design control and regulatory requirements (21 CFR Part 820, ISO 13485).
  • Experience with rapid prototyping, fixture design, and materials selection.
  • Excellent written and verbal communication skills.
  • Detail-oriented with strong organizational and project management abilities.

Job Type: Full-time

Benefits:

  • 401(k)
  • Dental insurance
  • Flexible spending account
  • Health insurance
  • Life insurance
  • Paid time off
  • Vision insurance

Schedule:

  • Monday to Friday

Work Location: In person

Posted 2025-10-07

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