Product Engineer

Scope of the Role

To design new medical devices and make design changes or improvements to existing medical devices. Supports projects as core team member to bring new designs or design changes through the applicable phases of the Design Control Process.

Duties and Responsibilities

• Functions as Core Team member on project team or serves as project leader for projects that are smaller in scope
• Follows through on assigned project activities through the applicable project phases to reach the final phase of Commercial Release for ongoing production
• Understands and follows procedure for elements of project execution to meet the requirements of the Design Control Process
• Applies the Risk Management Policy to the development process for identifying hazards, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of risk controls
• Utilizes engineering skills to optimize design and technology to drive innovation and significantly improve patient outcome
• Considers all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability
• Establishes product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance
• Provides detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device
• Develops protocols, test methods, and reports for execution of design verification and validation testing
• Clearly depicts connection between product requirements, design inputs, design outputs, and verification/validation in traceability matrix
• Participates in risk management activities as documented in Risk Management File, dFMEA, and pFMEA (design/process Failure Mode Effects Analysis)
• Evaluates and designs products, parts, or processes for cost efficiency to minimize the cost for patient care
• Completes project activities for Commercial Release of product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations
• Provides basic support on request for quotes by providing insight into project activities needed for new product introduction Works with other members of the engineering team to ensure that project phases are completed in a timely manner
• Upholds Spectrum Plastics Group vision and core values
• Follows all safety guidelines and adheres to safety absolutes