Senior Product Development Engineer

3 weeks ago


Atlanta, United States Biomedical Resource Consultants, Inc Full time

Job Description

Job Description

Senior Product Development Engineer Position Summary

:

Reporting to the VP of Research & Development, you will be responsible for the planning, organization and implementation of the design and development of devices within the company's product portfolio. Our client is a late-stage startup, entering ramp-up mode, who is developing a novel women's health technology platform. With four products on the market, and one more in late-stage development, they have developed a disruptive technology that is the only known alternative for a procedure that is currently being performed over 700K times a year. This hands-on role requires initiative, originality, ingenuity, and excellent problem-solving skills. You must have the ability to adapt and make decisions in a fast-paced environment to meet aggressive deadlines..

Specific Job Functions:

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

Minimum Qualifications, Education & Work Experience Desire and ability to manage R&D Manufacturing as the company grows Bachelor's degree in engineering (mechanical/ biomedical) or related scientific field

5+ years of experience in medical device mechanical design and manufacturing

2+ years of project management experience in medical device mechanical design and manufacturing

Hands-on experience with advanced SolidWorks or 3D CAD techniques (e.g. surface modeling)

Thrives 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)

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