- 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
- 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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Senior Product Development Engineer - Atlanta, United States - Biomedical Resource Consultants, Inc.
3 weeks ago
Description
Job Description
Job DescriptionSenior 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:
Minimum Qualifications, Education & Work Experience
