Principal R&D Engineer (medical devices)

Surf search; Irvine (CA); Vor Ort; USD 120.000 - 150.000; Vollzeit

Zusammenfassung

Surf Search is seeking a Principal R&D Engineer to lead cardiovascular implantable devices development at the flagship site in Irvine, CA. This role involves managing the full lifecycle of device development from concept to launch, including leadership of clinical testing.

The ideal candidate will have a Bachelor's in engineering, preferably mechanical or biomedical, with at least 7 years of relevant experience. Strong CAD skills, particularly in SolidWorks, are essential.

Qualifikationen

• 7+ years experience in developing cardiovascular implantable devices.
• Proficient in mechanical design of small parts for cardiac intervention.
• Strong technical knowledge of the cardiovascular implantable device industry.

Aufgaben

• Develop Class III cardiovascular implantable devices from concept to launch.
• Manage product development processes including prototyping and clinical testing.
• Deliver reports and technical summaries for clinical and regulatory submissions.

Kenntnisse

Cardiovascular implantable devices experience

Mechanical design knowledge

Strong communication skills

SolidWorks proficiency

Ausbildung

Bachelor's degree in engineering

Advanced degree preferred

Tools

CAD software

Jobbeschreibung

• Full-time

Company Description

Global medical devices leader seeks a Principal R&D Engineer to lead exciting new cardiovascular implant research and development projects at the company's flagship site in Irvine, CA.

Job Description

The Principal R&D Engineer will:

• Develop Class III cardiovascularimplantable devices from concept through launch. These could includeincluding catheter delivery systems, ICD, LVAD, stents, TAVR, heart valves or vascular grafts
• Manage product developmentprocess which will include concept development, defining and generatingdesign requirements, prototyping, and leadership of preclinical studies and clinicaltesting

Requirements

• Bachelor's degree in engineering; preferably in mechanical engineering or biomedical engineering - advanced degree preferred
• 7+ years full life cycle experience in the development of cardiovascular implantable devices such as ICD, LVAD, TAVR,catheters, pacemakers, heart valves, stents and/orvascular grafts
• Experience with a variety of metals typically used for cardiac implantables and delivery devices. Thesecould includestainless steels, nickel-titanium alloys, tantalum, cobalt-chromium alloys, andplatinum chromium
• Experience with mechanical design of small parts commonly used in cardiac repair and intervention
• Experience developing and running design verification testing for long term viability of implantable devices
• Experience writing and delivering reports and technical summaries supporting clinical submissions as well as submissions to applicable regulatory agencies
• A track record of technical accomplishment in developing Class III cardiovascular implantable devices
• Strong communications skills; oral, written and electronic
• The ability to work independently or as a leadin a cross functional environment
• Strong technical knowledge of the cardiovascular implantable deviceindustry landscape
• Experience with some of the following: product design, "hands on"prototyping, DFM - design for manufacturing, new process development, tech transfer from R&D to produciton
• Strong working knowledge of SolidWorks or other applicable product development CAD software