Senior Product Development Engineer
4 weeks ago
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 membersExperience 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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