Junior Project Engineer; Design Controls

Location: 100% ONSITE - Mahwah, NJ (07430)

Pay Rate – Negotiable depending on DIRECT-related experience up to $33.75 - $36.06 an hour

Work Authorization
:
Must be physically located in United States and have United States employment authorization documents WITHOUT
CURRENT OR FUTURE sponsorship requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.

• Assist in providing oversight to sustaining engineering teams with respect to implant and instrument design work.

• Model and detail implant and instrument designs utilizing ProE/Creo design software.
• Demonstrate technical protocol and report writing skills.
• Work on cross-functional design teams to address design and manufacturing changes and maintain existing designs.
• Utilize knowledge of the surgical procedure in order to develop innovative solutions to solve / satisfy customer needs.
• Support FDA and world wide submissions through design rationales and compliance to industry standards with an international team.
• Research legacy testing and design controls for evidence required.
• Perform tolerance analysis
• Draft technical memos

• Bachelor’s degree in a science or engineering discipline. (Mechanical or Biomedical Engineering preferred.)
• 1-2+ years of product design experience in medical device industry or other regulated industry
• Experienced in design controls and risk management within a regulated industry.
• Experienced with a parametric CAD design package. (Prefer ProE/Creo)
• Expertise with Finite Element Analysis (FEA) and its application, or expertise in other scientific or engineering discipline.
• Demonstrated ability to effectively communicate engineering principals to all levels within the organization through oral and written means.

Important information: To be immediately considered, please send an updated version of your resume to

*** (Kelly Services does not expense relocation/interview costs)