Sustaining R&D Engineer

Ultimate Staffing Services; Irvine (CA); On-site; USD 66,000 - 78,000; Full time

Job summary

Ultimate Staffing Services in Irvine, CA seeks a Sustaining R&D engineer to research and test device design, functionality, and maintenance. Key emphasis on testing protocols, documentation, and cross-functional collaboration within a regulated environment.

Requires a engineering or scientific degree with 5+ years (or 4+ years with a master's) and strong communication skills. This W-2 contract role lasts 12 months with on-site work in Irvine, CA.

Qualifications

• Bachelor's or Master's in Engineering or Scientific field with 5+ years (or 4+ years for MS) of experience.
• Medical device industry experience preferred.
• Strong documentation and communication skills.

Responsibilities

• Work cross-functionally with Quality, Manufacturing, Clinical, and Regulatory to support existing products.
• Test and/or improve products by developing complex experiments and tests, analyze results, and prepare reports.
• Create/update design control documents including requirements and risk files.
• Develop and execute engineering project plans.
• Evaluate and guide suppliers, setting tolerances and acceptance criteria.
• Assign R&D tasks, supervise technicians, and provide feedback.
• Analyze inputs and draft technical recommendations for parts and subsystems.
• Review historical technical documentation to identify gaps or leverage for justification.
• Other duties assigned by Leadership.

Skills

MS Office Suite

CAD

Technical reading

Statistical methods

Documentation

Communication

Teamwork

Problem solving

Education

Engineering or Science degree with 5+ years OR MS with 4+ years

Tools

MS Office Suite

CAD software

Job description

Salary: USD48 - USD56.8 per hour

W-2 Contract Role

Duration - 12 Months

Location - Irvine, CA 92614

Pay - $48 to $56.80/hour

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.

Job 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

Education/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

What else we look for (Preferred):

• 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.
• 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