Product Development Engineer

Manage multiple engineering projects and deliverables while working closely with global cross-functional teams. Job Responsibilities Lead R&D deliverables throughout the medical device design control process, focusing on intravenous infusion sets and connection devices.

Job Title: Product Development Engineer
Location: Brea, CA

Employment Type: Contract

Job Responsibilities

• Lead R&D deliverables throughout the medical device design control process, focusing on intravenous infusion sets and connection devices.

• Collaborate with cross-functional teams to plan, develop, modify, implement, and support product development activities.

• Develop technical plans, define design inputs and outputs, and conduct analytical and empirical feasibility studies.

• Develop test methods, write test protocols and reports, and execute design verification and validation testing.

• Identify and resolve product design and testing issues using engineering fundamentals and Design for Six Sigma (DFSS) principles.

• Support product design transfer activities in collaboration with Manufacturing and Operations.

• Prepare and maintain design documentation to support global regulatory filing requirements.

• Manage multiple engineering projects and deliverables while working closely with global cross-functional teams.

• Work primarily in the laboratory and office, with an onsite presence of more than 80% in Brea, CA.

Required Qualifications

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

• Minimum 5 years of relevant experience, or 3 years with an advanced degree.

• Experience with medical device product development and design control processes.

• Hands-on experience with design control documentation, including requirements, test protocols, and reports.

• Proficiency in SolidWorks or an equivalent CAD tool.

• Knowledge of engineering principles, design verification, validation, and DFSS principles.

• Ability to manage multiple projects and work effectively with cross-functional teams.

• Strong analytical, critical-thinking, communication, and problem-solving skills.

Pay Scale:
Anticipated hourly pay range $45 $56 per hour on W2 Benefits:
Employees hired into this position are eligible for the following benefits, subject to the 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.