Mechanical Engineer

Mechanical Engineer

Location: Torrance, CA.

Job Description

Company 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 challenges

Requirements

• 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.