Position Title: Sustaining R&D Engineer Work Location: Irvine, CA 92614 Assignment Duration: 12 Months Work Arrangement: Onsite
Position Summary:
The main function of a Sustaining R&D engineer is to research and test the design, functionality and maintenance of products, equipment, systems and processes.
Device testing and technical justification/writing are key skills.
Key Responsibilities:
Work in a cross-functional environment (Quality, Manufacturing, Clinical, and Regulatory) to support existing commercialized products.
Test and/or improve products by developing complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles, especially for design verification
Generate work instructions, test methods, engineering models and drawings/prototypes, etc., to establish/characterize product and/or process specifications
Create/update more complex design control documents including requirement specs, and risk documents
Develop and execute engineering project plans
Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers
Assign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work
Evaluate input and form a technical recommendation including designing parts, components and subsystems
Understand and review historical technical documentation to identify gaps or for ability to leverage for technical justification
Other duties assigned by Leadership
Qualification & Experience:
Bachelor's Degree in Engineering or Scientific field with 5+ years of experience – OR - Master's Degree in Engineering or Scientific field with 4+ years of experience
Medical device industry experience is highly preferred
Substantial understanding and knowledge of principles, theories, and concepts relevant to Engineering
Knowledge of materials and processes for catheter construction and manufacturing
Strong documentation, communication (e.g., written and verbal) and interpersonal relationship skills including consultative and relationship management skills
Proven expertise in usage of MS Office Suite; CAD experience preferred
Ability to read and interpret technical drawings, schematics, and computer-generated reports.
Minitab experience preferred
Basic understanding of statistical techniques
Previous experience working with lab/industrial equipment
Strong problem-solving, organizational, analytical and critical thinking skills
Substantial understanding of processes and equipment used in assigned work
Strict attention to detail
Ability to interact professionally with all organizational levels
Ability to manage competing priorities in a fast-paced environment
Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects
Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's pay range is $52.00/hr - $57.95/hr.
