39 applicants

Company

Original Job Post

Femasys Inc. · 3 days ago

Product Development Engineer

Suwanee, GA

Full-time

Onsite

Senior Level

7+ years exp

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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.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical device mechanical designProject managementSolidWorks3D CADStart-up experienceEager to learnMedical Device DirectiveISO 13485FDA design controlsProduct manufacturingInjection moldingMetalsMetallic stampingPolymersExtrusionsCoating technologies3D printingRisk AnalysisFMEAProcess validationQuality system regulationsProblem-solvingHard-workingTime managementCommunication

Required

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

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).

Benefits

Competitive salary and benefits package.

Professional development and growth opportunities.

Company

Femasys Inc.

Femasys is a biomedical company focused on transforming women’s healthcare worldwide by developing novel solutions and next-generation advancements providing significant clinical impact to address severely underserved areas.

Founded in 2004

Suwanee, Georgia, USA

11-50 employees

http://femasys.com

H1B Sponsorship

Femasys Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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