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)