Senior R&D Engineer

Job Title: Senior R&D Engineer

Job Location: Irvine, CA

Job Type: Contract

Job Overview:

Pay Range: $51.82hr - $56.82hr

Requirement/Must Have:

• 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.
• 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 and interpersonal relationship skills including consultative and relationship management skills.
• Proven expertise in usage of MS Office Suite.
• 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.

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 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.
• Perform other duties assigned by Leadership.

Nice to Have:

• Medical device industry experience is highly preferred.
• CAD experience preferred.
• Minitab experience preferred.

Skills:

• Device testing.
• Technical justification.
• Technical writing.
• Design verification.
• Design control.
• Project planning.
• Supplier management.
• MS Office Suite.
• CAD.
• Minitab.
• Statistical techniques.

Qualification And Education:

• Bachelor s Degree in Engineering or Scientific field.
• Master s Degree in Engineering or Scientific field.

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• Medical, Dental, and Vision Insurance
• 401(k) Retirement Plan
• Health Savings Account (HSA)
• Disability Insurance (Short-Term and Long-Term)
• Life and AD&D Insurance
• Paid Sick Leave (where required by applicable state or local law)
• Supplemental Insurance Plans
• Identity Theft Protection
• Pet Insurance
• Employee Wellness Programs
• Employee Assistance Program (EAP)
• Career Growth and Professional Development Opportunities