Global medical device company in Irvine is seeking a Sr. R&D Engineer to join their growing team!
- Support the development of critical care devices or subsystems thereof from concept to commercial launch
- Apply engineering principles to the design of electro mechanical medical devices, effectively use tests and simulations to expedite development in a fast paced environment
- Design, prototype and test components of medical devices, develop new test methods to evaluate devices
- Work with internal and external resources to contribute to the design and development, testing and release of electromechanical components used in medical device systems
- Solve technical issues working as a contributing member of a diverse engineering team Integrate development of medical technology by assuring the design of technology interfaces and system elements works together as a whole
- Write design verification and validation protocols and reports in accordance with quality procedures assuming full ownership as the Study Director Provide solutions to the technical aspects of product design and development as well as the translation of marketing requirements into product specifications
- Work with R&D technical teams (Mechanical, Electrical, Systems, Software) and internal partners in the Marketing, Regulatory, Quality, Clinical, Manufacturing and other departments to deliver project objectives
- Must have good 3D CAD skills in SolidWorks
- Must have demonstrated the ability to solve engineering problems, through testing, analysis, simulation (FEA, CFD) modeling etc.
- Working knowledge of basic statistics and six-sigma principles
- Requires strong technical aptitude, leadership, communication, writing and coordination skills
- Requires a high-energy individual who has excellent teamwork, partnering, and negotiation skills
- Must be a highly motivated self-starter who is able to achieve results with minimal direction
- Must be proactive and creative in achieving goals
- Must have strong conflict resolution skills
- Previous mechanical design experience with disposable devices, capital equipment, and/or sensors (pressure, flow, optical).
- Proficiency in mechanical design, tolerance stack-up analysis, design for Manufacturability (DFM), and specification development
- Experience in design verification & validation within an FDA regulated industry
- Experience with design control procedures
- Experience with Solidworks, LabView, MatLab, and quantitative analysis of data
- Knowledge of relevant manufacturing processes like injection molding, extrusion etc.
- Comfortable in a dynamic working environment with multiple priorities
- Bachelors Degree in Mechanical Engineering with a minimum of 5 years experience (Masters or PhD degree lessens the experience required for the position)
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178
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WHAT WE DO:
Apex Systems is a division of the 2nd largest IT staffing and services firm in North America. From consulting to staff augmentation, we connect top tech talent with great companies in all industries.
Apex earned Inavero’s Best of Staffing™ Client Diamond and Talent Awards for providing superior service to clients and job seekers, putting the company in the top 2 percent of all U.S. staffing agencies.
SUPPORTING OUR CONTRACT EMPLOYEES:
We take the time to understand a candidate’s talents and needs to ensure a good match with companies for contract, contract-to-hire, and direct hire positions. Each recruiter within Apex is focused on a specific skill area within infrastructure, applications, and project management. This focused discipline enables our local recruiters to work directly with our candidate’s and focus their talent on the right position at the right time.
WHO OUR CUSTOMERS ARE:
We serve Fortune 500, mid-market, and emerging companies from a wide variety of industries, including communications, energy, financial services, government services, healthcare, technology, and utilities.
WHERE WE ARE:
Apex has branches in over 70 locations across the U.S. and Canada and more than 1,000 employees dedicated to supporting the needs of our clients and contract team members. Visit www.apexsystems.com to find a local branch or connect with an Account Manager or Recruiter.
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