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Product Development Engineer

3 months ago

Suwanee, United States Femasys Inc Full time

About Femasys Inc.

Femasys Inc. is a leading biomedical company dedicated to advancing womens healthcare through innovative medical solutions. Our mission is to provide safe, effective, and accessible products that improve the lives of women worldwide.

About the Role:

Responsible for the planning, organization, and implementation of the design and development of devices within Femasys product portfolio. This hands-on role requires initiative, originality, ingenuity, and excellent problem-solving skills.

Responsibilities:

  • Oversee the R&D manufacturing process.
  • Ensure the timely completion and budget of projects with priorities established and agreed upon with R&D leadership.
  • Lead or support the conceptualization, planning, and design of new products; Risk assessment; Prototype design and testing; Design reviews; Design verification testing; R&D product manufacturing process development; Product validation and usability testing.
  • Designs/develops components, products, processes, fixtures, and test systems.
  • Conducts and/or contracts testing to evaluate components, products and processes.
  • Creates testing protocols, engineering specifications, drawings, technical reports, and other product documentation.
  • Provides input on improvements for current manufacturing and/or new processes for future devices. Provides input on new product development initiatives.
  • Fabricates or oversees production of prototype product, pre-clinical product, and manufacturing equipment/ tooling fabrication.
  • Procurement of capital equipment and tooling
  • Train and guide lower-level engineers and production personnel.

Qualifications: Education details

  • Bachelor's degree in engineering (mechanical/ biomedical) or related scientific field.

Required Skills:

  • Minimum 7 years of experience in medical device mechanical design and manufacturing.
  • Minimum 2+ years of project management experience in medical device mechanical design and manufacturing.
  • Hands-on experience with SolidWorks or 3D CAD techniques.
  • Previous experience working at a small or start-up medical device company.
  • Thrive in a fast-paced environment, is motivated and eager to learn.
  • Excellent time management skills and comfortable working on multiple projects at once.
  • Experience effectively communicating project concepts, ideas and information to supervisors, operators and other team members.
  • Experience with Medical Device Directive (MDD), ISO 13485, FDA design controls.
  • Good understanding of product manufacturing, e.g., injection molding, metals and metallic stamping processes, polymers, extrusions, coating technologies, 3D printing, etc.
  • Good understanding of Risk Analysis, FMEA, and process validation.
  • Working knowledge of quality system regulations (FDA and ISO).

Why Join Femasys Inc ?

  • Opportunity to make a significant impact on womens healthcare through innovative products.
  • Collaborative and inclusive work environment.
  • Competitive salary and benefits package.
  • Professional development and growth opportunities.

Equal Employment Opportunity Policy

Femasys, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.