Product Development Engineer III

JOB PURPOSE :

To design new devices / components and make design changes or improvements to existing devices / components. Leads major programs to bring new designs or design changes through the applicable phases of the Product Development Process.

ESSENTIAL DUTIES :

• Functions as leader for major programs involving all phases of product design and development, leading Core Team through the execution of project activities
• Follows and improves the Product Development Process to ensure regulatory requirements are met and that the medical device meets the requirements for its intended use
• Plans and drives execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production
• 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
• Guides the project team through use of design and technology to drive innovation and significantly improve patient outcome
• Strives for improvement to ensure all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability
• Diligently develops product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance
• Oversees creation of detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device
• Develops verification and validation plans for the protocols, test methods, and reports for execution of design verification and validation testing
• Able to navigate completely new medical devices through product requirements, design inputs, design outputs, and verification / validation in traceability matrix
• Introduces design mitigations to significantly reduce the risk profile for the medical device 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
• Coordinates project activities for Commercial Release of expansive product lines and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations
• Leads Core Team to ensure that project phases are completed in a timely manner
• Defines activities for project execution to meet the requirements of the Product Development Process
• Supports request for quotes, specifically complex devices that vary greatly from predicates
• Upholds Spectrum Plastics Group vision and core values
• Follows all safety guidelines and adheres to safety absolutes

QUALIFICATIONS (Education / Experience / Knowledge, Skills & Abilities)

Required :

Preferred :

WORKING CONDITIONS :

Works with minimal supervision from manager. Requires light physical activity performing non-strenuous daily activities

NOTE : This job description is not intended to be an exhaustive list of all possible duties, responsibilities and or qualifications. Other duties, responsibilities and / or qualifications may be assigned to this position.