Mechanical Engineer

Company: Kelly
Location: Torrance
Posted on: August 7, 2022

Job Description:

Mechanical Engineer Location: Torrance, CA.Job DescriptionCompany seeking a talented and passionate Medical Device Mechanical Engineer to join its R&D team to support the development, improvement, and clinical trial of its implantable heart pump CH-VAD -.The right applicant will also engage in R&D activities related to company's pipeline products including wireless charger and portable extracorporeal life support (ECLS) device.Responsibilities --- Product design and development support from concept to post product launch --- Generate solid models, drawings, and bills of materials --- Create design specs, protocols, and V&V reports[PS(1] --- Develop Design History Files (DHF) and Risk Management Files --- Perform basic structural and thermal analysis if needed --- Design test fixtures, build prototypes, and conduct lab testing --- Support HFUE in product design per FDA requirements [PS(2] --- Interface with vendors related to PO and MRB issues --- Collaborate with ISC to address manufacturing issues --- Work with global team and consultants to overcome technical challengesRequirements --- BS degree in Mechanical Engineering or related field --- Ventricle Assist Device (VAD) & Mechanical circulatory support experience (MCS) preferred --- 5+ years of professional experience in 3D CAD modeling --- 3+ years of professional experience in Class III medical device R&D --- Proficient in creating component/assembly drawings and BOM --- Experienced in geometric dimensioning & tolerancing --- Experienced in design documentation including URS, PRS, DRS, and V&V reports --- Familiar with manufacturing process, DFM and DTC --- Familiar with medical device regulations and standards: 21 CFR 820; ISO 14971, 13485, 60601; FDA Human Factors Guidance, etc. --- Strong interpersonal communication and technical writing skills --- Ability to work in a dynamic, multi-lingual environment --- Up to 25% travel --- Legally authorized to work in the U.S.

Keywords: Kelly, Torrance , Mechanical Engineer, Engineering , Torrance, California