Mechnical Validation Engineer

Job Title - Mechnical Validation Engineer

Location - San Diego, CA

Duration – 12+ Months Contract

Total Hours/week - 40.00

1st Shift

Client: Medical Device Company

Job Category: Engineering

Level Of Experience: Seniority Level

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

• Work hours: 40 hrs./week from 8am-5pm

• Mostly on-site due to the need to be in the lab for test method development/validation activities. Remote work is acceptable for tasks that can be performed remotely.

• 3 Must haves on the resume:

1. Strong experience with test method development/validation in medical device industry

2. Strong Experience with design verification planning, developing protocols and execution.

3. Clear communication skills and experience working with cross-functional teams.

This position will be a core part of BD’s design verification and validation (V&V) team focusing evaluation of design history files for BD’s disposable IV product line and development/execution of design verification plans and protocols. Working under a general direction of the V&V Manager, the R&D engineer will review and select groups of BD products that will undergo design verification tests, develop and execute test protocols and write test reports. In addition, the R&D engineer is expected to have a working knowledge in developing and validation of test methods required for design verification.

Responsibilities

• Apply Mechanical/Medical Device engineering knowledge to rationalize selection of representative performance verification tests based on product design characteristics and requirements.

• Develop and execute test protocols while working closely with engineers and lab technicians on the team

• Interact with product development and R&D teams to leverage engineering fundamentals and shared experience

Qualifications

• Graduating Engineer or B.S. Degree in Mechanical Engineering or Biomedical Engineering with experience in developing test protocols and test methods

• Experience with planning and executing design verification activities (e.g. Design Verification Plans, Design Verification Protocols, Test Method Development and Validation)

Knowledge of statistical analysis of experimental data and inferential statistics

• Ability to effectively communicate with the technical team to inform decision making

• Eagerness to work on broad and challenging engineering assignments involving analytical reasoning, test protocol development and execution

• Experience working in a lab environment, testing mechanical components, experience working in high volume plastics manufacturing.

• Effective written and verbal communication