Sustaining R&D Engineer

Ultimate Staffing; Irvine (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Ultimate Staffing seeks a Sustaining R&D Engineer in Irvine, CA to research, test, and maintain medical devices. This role emphasizes device testing, design verification, and strong technical justification.

You will work cross-functionally with Quality, Manufacturing, Clinical and Regulatory, develop complex experiments, write protocols, and create/update design control documents. Education: Bachelor's in Engineering or Science with 5+ years, or Master's with 4+ years; medical device experience

Qualifications

• Bachelor's Degree in Engineering or Scientific field with 5+ years of experience, or Master's with 4+ years.
• Experience in medical device industry preferred.
• Strong documentation and communication skills.

Responsibilities

• Support existing products in cross-functional teams (Quality, Manufacturing, Clinical, Regulatory).
• Test and improve products by designing complex experiments and protocols, analyzing results, and writing reports.
• Create and update design control documents, risk assessments, and requirement specifications.
• Develop and execute engineering project plans and manage supplier evaluations.
• Train technicians, assign R&D tasks, and coordinate testing activities.
• Review historical technical documentation to identify gaps and justify changes.

Skills

Medical device industry experience

Strong documentation & communication

CAD experience

MS Office proficiency

Statistical techniques knowledge

Read technical drawings

Team collaboration

Project management

Education

Bachelor's Degree in Engineering or Scientific field

Master's Degree in Engineering or Scientific field

Tools

MS Office Suite

CAD software

Minitab

Job description

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.
• 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

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, Los Angeles County Fair Chance Ordinance, and San Francisco Fair Chance Ordinance.