Product Development Engineer

Title : Product Development Engineer

Location: Brea, CA ( Onsite )

Duration : 6 Months +

Employment Type: Contract

Job Responsibilities

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

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

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

• Develop test methods to verify and validate product subsystems and systems.

• Prepare and execute design verification testing to confirm design outputs meet design input requirements.

• Develop test protocols, execute testing, troubleshoot design and testing issues, and prepare technical reports.

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

• Prepare design documentation to support global regulatory filing strategies.

• Apply engineering fundamentals, Design for Six Sigma (DFSS) principles, and statistical techniques to product development activities.

Required Qualifications

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

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

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

• Experience creating and maintaining design control documentation.

• Proficiency in SolidWorks or an equivalent CAD tool.

• Ability to manage multiple projects of varying scopes simultaneously.

• Experience working independently with moderate guidance and collaborating across cross-functional teams.

• Strong critical-thinking, technical problem-solving, written communication, and verbal communication skills.

Pay Scale

• Anticipated hourly pay range: $45/hr to $56/hr 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.