Engineer III, Product Development Engineer

Job Title: Engineer III, Product Development Engineer
Location: Bay area, CA
Employment Type: Contract - W2

Job Responsibilities

• Lead and support R&D activities for intravenous infusion sets and connection devices throughout product development and lifecycle management.

• Develop requirements, design inputs, design outputs, and technical plans in accordance with medical device design control processes.

• Conduct analytical and experimental feasibility studies to evaluate and refine product designs.

• Develop test methods, write test protocols and reports, and execute design verification testing to confirm that design outputs meet design input requirements.

• Troubleshoot product design and testing issues using engineering fundamentals, statistical analysis, design of experiments (DOE), and Design for Six Sigma (DFSS) principles.

• Support verification and validation of subsystems and systems and transfer designs to Manufacturing and Operations.

• Create and maintain design control documentation supporting global regulatory submissions.

• Collaborate with Quality, Manufacturing, Regulatory, Clinical, Marketing, and other cross-functional teams.

• Manage multiple projects and deliver technical objectives with moderate guidance.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Materials Engineering, or Biomedical Engineering.

• At least 5 years of relevant work experience, or 3 years of relevant experience plus an advanced degree.

• Experience with medical device product development, design controls, and creating and maintaining design control documentation.

• Experience developing test methods, authoring test protocols and reports, and executing verification testing.

• Proficiency with SolidWorks or an equivalent CAD tool.

• Working knowledge of statistical techniques and DOE.

• Strong critical thinking, troubleshooting, leadership, and written and verbal communication skills.

• Ability to lead or contribute to cross-functional teams and manage multiple projects of varying scope.

• Ability to work onsite in Brea, CA, more than 80% of the time.

Pay Scale

Anticipated hourly pay range: $45/hr to $56/hr on W2, with limited flexibility for exceptionally strong candidates.

Benefits

Employees hired into this position are eligible for the following benefits, subject to applicable plan terms and eligibility requirements:

Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.

Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.

Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.