R&D Engineer (Onsite Irvine, CA)

About the role

The R&D Engineer supports project teams in the development of medical devices. This includes writing or verifying specifications, developing testing and product processes, and designing fixtures, to ensure the concepts and/or prototypes meet requirements.

Responsibilities

• Research, design, develop, modify, and verify components/modules for medical device product development and/or misc. activities.
• Translate and/or define design inputs to engineering specifications and produce sub-system level designs.
• Apply fundamental concepts, practices and procedures to problem solving.
• Demonstrate understanding of customer needs and design inputs.
• Demonstrate understanding of product’s intended use and clinical procedures.
• Learn how the financial models are constructed.
• Follow fundamental industry standards, design requirements, and test strategies which apply to regulatory requirements.
• Create or refine engineering documentation, such as the Design History file.
• Follow R&D procedures like design controls and risk management, per the Quality Management System.
• Collaborate with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.

Requirements

• Bachelor of Science Degree in Engineering; Mechanical Engineering or Biomedical plus 0+ years of relevant work experience.
• Preferred qualifications include a Master of Science Degree in Engineering, Mechanical Engineering or Biomedical.
• Working knowledge and understanding of mechanical engineering practices and design principles within a regulated environment.
• Technical ability to create engineering drawings and models, applying GD&T and CAE tools.
• Demonstrated ability to apply knowledge of materials and manufacturing processes to product design.
• Knowledge of Machine Shop and 3D printing practices.
• Knowledge of Medical Device Manufacturing.

Qualifications

Commensurate with experience.

Skills

• Strong technical skills in mechanical engineering and biomedical engineering.
• Ability to work independently and as part of a team.
• Excellent communication and problem-solving skills.
• Understanding of regulatory requirements and industry standards.

Benefits

• Health benefits: Medical, prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program, and tobacco cessation program.
• Financial benefits: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Pay

$79,900 - $127,500 USD Annual

Schedule

N/A

Benefits

• Personalized healthcare support.
• Wellbeing program.
• Tobacco cessation program.

Stipulations

Depending on customer requirements, employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.