Staff Mechanical Engineer - KORE1 Technologies
Irvine, CA
About the Job
KORE1, a nationwide provider of staffing and recruiting solutions, has an immediate opening for a Staff Mechanical Engineer in Irvine, California.
The Staff Mechanical Engineer provides engineering and design services to Advanced R&D. This includes ideation, developing concepts and prototypes, creating test methods, supporting preclinical/clinical testing of the device, and supporting technical transfer. This position will have responsibilities across Cardiovascular and Specialty Solution (CSS) Companies including a span of multiple product platforms such as Electrophysiology, Neurovascular, Vision, and Surgical and Non-Surgical Aesthetics.
Key Duties:
- Designs new devices based upon customer need
- Optimizes processes for initial and long-term scaling of new designs and processes for the designs
- Works directly with other engineers and skilled technicians to build and optimize designs
- Tests design prototypes and modifies design based upon test results
- Participates in in vitro and in vivo device testing
- Documents design and performs testing for V&V activities
- Manages the transfer of designs from concept to pilot to full production
- Works with cross-functional quality, medical affairs, and manufacturing teams
- Motivates and mentors others
- Creates IP and works with patent attorneys to ensure patents are applied for
- Responsible for communicating business related issues or opportunities to next management
level
- Responsible for ensuring personal and Company compliance with all Federal, State, local and
- Company regulations, policies, and procedures
- Company guidelines related to Health, Safety and Environmental practices and that all
resources needed to do so are available and in good condition, if applicable
- Performs other duties assigned as needed
Qualifications:
Required:
- A minimum of a BS in physics, chemistry, biology, mechanical, electrical, biomedical engineering, or related field
- A minimum of 6+ years of engineering work experience, with 2+ years of experience in the medical device industry
- Ability to travel up to 10%, domestic and international
- A minimum of 1 year of experience working in a pre-clinical or clinical environment
Preferred:
- Knowledge of geometric dimensioning and tolerancing (GD&T)
- Strong knowledge of CAD software including SolidWorks
- Able to interpret 2D engineering drawing
- Previous experience in cardiac electrophysiology
- Previous experience working with physicians
- 2+ years of R&D experience
- Understanding of quality standards pertaining to medical device
- Experience with statistical analysis and design of experiments (DOE)
- Knowledge of engineering materials such as nitinol, precious metals, and/or polymers and manufacturing techniques related to the materials
- Ability to work with patent attorneys to secure IP
ABOUT KORE1
Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.
Specializing in professional and technical recruiting, KORE1 is committed to supporting top IT, Engineering, Creative, Scientific, Accounting and Finance professionals in their career paths. We build deep relationships with leading companies, connecting them to exceptional talent every day. With extensive industry expertise and unmatched opportunities, our goal is to provide a unique experience for our contractors and consultants as they prepare for their next role. We are passionate about matching the right people with the right companies.
Kore1 provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kore1 complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training. Kore1 expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Kore1's employees to perform their job duties may result in discipline up to and including discharge.
Source : KORE1 Technologies