Sr. R&D Engineer

12+ month W2 contract role in Franklin Lakes, NJ for a medical-device R&D team. Pay rate $40–55/hr; US citizens or Green-Card holders only.

About the role

Research and Development Engineering is responsible for developing and implementing new products through adherence to established design-control processes and good engineering and documentation practices. The role requires a working knowledge of engineering principles, product design and development, and the design-control process. You will test, analyze, and solve technical problems with moderate guidance, apply basic statistical techniques, and utilize design of experiments. You will translate customer needs into design inputs, verify that design outputs meet those inputs, and work with moderate guidance to translate requirements into basic designs, create and test prototypes, and map the intellectual-property landscape.

Responsibilities

• Gather user needs and translate them into technical inputs.
• Develop viable Design Verification and Validation (V&V) plans.
• Participate in or lead product-development projects, establishing a successful track record.
• Apply working knowledge of medical-device risk management.
• Assess root causes of issues and propose solutions.
• Identify project risks and develop mitigation plans.
• Use CAD software (e.g., ProE, SolidWorks) in the design process.
• Perform statistical analyses (t-tests, ANOVAs, capability analyses) using tools such as Minitab.
• Create, manage, and audit Design History Files for medical devices.
• Ensure compliance with design-control regulations (MDD, MDR) and standards.

Requirements

• BS in Mechanical Engineering or Biomedical Engineering (required).
• MS in a closely related field (preferred).
• 3+ years of experience in the medical-device industry, specifically in product development/R&D.
• Hands-on experience with design control and at least three years in the medical-device field.
• Strong communication and written skills.
• Statistical background and experience with root-cause analysis.
• Self-starter with agility, flexibility, and a quick-learning mindset.
• Strong work ethic aligned with company values.

Pre-qualifying questions

Each resume must include answers to the following:

• How familiar are you with design control, MDD, MDR, and standards compliance?
• What is your experience in creating, managing, or auditing Design History Files for medical devices?
• What is your experience with creating Design Verification plans, protocols, or reports?
• Have you ever performed root-cause analyses? If so, describe.
• What is your experience using statistical software (e.g., Minitab)? Have you performed t-tests, ANOVAs, capability analyses, etc.?
• What has been your most challenging problem from a Verification and Validation perspective, and how did you solve it? Who did you involve, and what was the outcome?
• What are your top three responsibilities in your current position, and what percentage of time do you spend on each?
• What is your experience with CAD software (e.g., ProE, SolidWorks)?