Product Development Engineer

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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