Product Development Engineer

<p>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.&nbsp;Our products have been organically conceived, researched, developed, and manufactured by the Company to ensure compliance with the FDA and ISO requirements.&nbsp;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.&nbsp;&nbsp;</p><p><br></p><p><span>Responsibilities:</span></p><ul><li>Involved in the planning, organization and implementation of design activities and testing for new and/or revised medical devices.</li><li>Responsible for recommending, initiating, improving, and supporting projects.</li><li>Designs/develops components, products, processes, fixtures, and test systems.&nbsp;</li><li>Performs duties and tasks from product concept to product commercialization.</li><li>Conducts or contracts testing to evaluate components, products and processes.</li><li>Creates protocols, engineering specifications, drawings, work instructions, and technical reports</li><li>Ensures compliance to FDA and ISO requirements, including GMP, and maintains efficiency in the manufacturing processes and quality of the products.</li></ul><p><br></p><p><span>Minimum Requirements &amp; Experience:</span></p><ul><li>Bachelor degree in Engineering (Mechanical/Biomedical) or related scientific field.&nbsp;</li><li>Analytical and experimental skills commensurate with Engineering education and experience.</li><li>General computer software aptitude that includes; word processing, spreadsheets, and statistical analysis software.</li><li>Experience with 3D CAD software (SolidWorks).</li><li>Excellent time management skills and comfortable working on multiple projects at once.</li><li>Works well in a fast paced team environment.</li></ul><p><br></p><p><span>Preferred Qualifications, Education &amp; Work Experience</span></p><ul><li>Experience working within an FDA regulated industry (medical device or pharmaceutical).</li><li>Experience working in a startup or small medical device company environment.</li><li>Previous experience with product or component manufacturing, e.g., injection molding, polymer extrusions, etc.</li><li>Previous exposure to Risk Analysis, FMEA, design controls, and process validation.</li></ul><p><br></p>

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