Product Development Engineer
Femasys Inc. is a rapidly growing medical device company committed to transforming women's healthcare worldwide by expanding options for women with innovative medical devices and next generation advancements. Our products have been organically conceived, researched, developed, and manufactured by the Company to ensure compliance with the FDA and ISO requirements. Femasys has achieved significant milestones to date including numerous issued patents and clearance of multiple regulatory filings by the U.S. FDA, European Union, Canada, and Japan.
Responsibilities:
- Involved in the planning, organization and implementation of design activities and testing for new and/or revised medical devices.
- Responsible for recommending, initiating, improving, and supporting projects.
- Designs/develops components, products, processes, fixtures, and test systems.
- Performs duties and tasks from product concept to product commercialization.
- Conducts or contracts testing to evaluate components, products and processes.
- Creates protocols, engineering specifications, drawings, work instructions, and technical reports
- Ensures compliance to FDA and ISO requirements, including GMP, and maintains efficiency in the manufacturing processes and quality of the products.
Minimum Requirements & Experience:
- Bachelor degree in Engineering (Mechanical/Biomedical) or related scientific field.
- Analytical and experimental skills commensurate with Engineering education and experience.
- General computer software aptitude that includes; word processing, spreadsheets, and statistical analysis software.
- Experience with 3D CAD software (SolidWorks).
- Excellent time management skills and comfortable working on multiple projects at once.
- Works well in a fast paced team environment.
Preferred Qualifications, Education & Work Experience
- Experience working within an FDA regulated industry (medical device or pharmaceutical).
- Experience working in a startup or small medical device company environment.
- Previous experience with product or component manufacturing, e.g., injection molding, polymer extrusions, etc.
- Previous exposure to Risk Analysis, FMEA, design controls, and process validation.