Mechanical Engineer

Sedaa•Pleasanton, CA

78d•$50,000 - $90,000•Onsite

About The Position

Performs complex activities in the testing and sustaining of class II and class III mechanical circulatory support products including Ventricular Assist Devices (VADs), extracorporeal blood pumps, and oxygenators. Provides technical solutions to a wide range of difficult problems. Exercises considerable latitude in determining technical objectives and solutions of assignments.

Requirements

B.S. in Mechanical, Biomedical, or Manufacturing Engineering.
8+ years engineering experience including product development, process development, risk assessment, and V&V verification related to class II/III medical devices
Industry experience with FDA design controls 21 CFR 820.30
Strong communication and presentation skills (e.g. versatility communicating with peers, management, auditors/regulators, and customers)
Ability to travel approximately 10%, primarily in the US, but may include international)

Nice To Haves

Design and V&V of class II/III electromechanical medical devices, such as VADs, extracorporeal blood pumps, oxygenators, or other implantable devices
Experience with medium to high volume medical device manufacturing
Experience with a variety of manufacturing processes and designing for manufacturability Industry experience with EU MDR, ISO 13485, and standards for medical devices (e.g. biocompatibility, sterilization, labeling, packaging, etc.)
Experience with CAD design, SPC/six sigma, DOE, and project management

Responsibilities

Research, test, and sustain electromechanical devices for VAD applications
Work with cross-functional teams for development of new products, and improvement to existing products driven by corrective and preventative actions (CAPA)
Use experimental, empirical, and numerical analysis to evaluate designs.
Develop and qualify (IQ/OQ) fixtures/equipment for verification testing
Investigate issues and identify root causes in complex systems where analysis of situations or data requires an in-depth evaluation of various factors
Identify and mitigate technical risks
Create/review technical drawings for appropriate assembly, dimensioning, and tolerancing
Knowledgeable in GD&T
Able to review/create tolerance analysis of existing systems
Understands complex machined parts, injection molded parts, extrusions, molding of silicone
Wide range of assembly techniques (laser welding, ultrasonic welding, bonding, mechanical joining)
Experience with risk management FMEA's
Aid in vendor evaluations such as manufacturing capability and capacity, engineering support, and quality controls
Complies with FDA regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.