Product Development Engineer II

Description

JOB PURPOSE
To design new devices/components and make design changes or improvements to existing devices/components. Leads or is a team member on projects to bring new designs or design changes through the applicable phases of the Product Development Process.

ESSENTIAL DUTIES
•    Functions as leader or team member for projects involving all phases of product design and development, leading Core Team through the execution of project activities
•    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
•    Optimizes design and technology to drive innovation and significantly improve patient outcome
•    Ensures 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 and participates in creation of 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 
•    Verifies connection between product requirements, design inputs, design outputs, and verification/validation is clear in traceability matrix 
•    Leads and ensures thoroughness of 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 
•    Coordinates project activities for Commercial Release of product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations
•    Defines activities for project execution to meet the requirements of the Product Development Process
•    Supports requests for quotes by outlining necessary project activities and timing for new product introduction
•    Upholds Spectrum Plastics Group vision and core values
•    Follows all safety guidelines and adheres to safety absolutes

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.

Qualifications

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required
•    Bachelor’s degree in engineering or equivalent experience in a related field. 
•    3-7 years industry experience
•    Demonstrated history to problem solve, identify errors and deficiencies and perform research 
•    High degree of understanding of ISO 13485 requirements for Design Controls 
•    Ability to provide guidelines and instructions applicable to the job function
•    Accuracy, attention to detail, and thoroughness
•    Proficient computer skills 
•    Proficient communications skills
•    Ability to comprehend and comply with company safety and quality standards
•    Ability to provide oral and written instructions to others

Preferred
•    Master’s degree in engineering discipline
•    Experience as project manager on a project which involved all phases of product design and development, leading Core Team through the execution of project activities
•    Knowledge on developing full-scale project plans 
•    Effectively communicated project expectations to team members and stakeholders in a timely and clear fashion
•    Experience planning and driving execution of project activities through the applicable project phases to the final phase of Commercial Release for ongoing production
•    Has knowledge of commonly used concepts, practices, and procedures within medical device design and development
•    Can handle financial responsibilities for project such as budget accountability and revenue recognition
•    Experience developing Gantt Charts in Microsoft Project
•    Demonstrated ability to complete product design transfers

WORKING CONDITIONS
Works with supervision from manager as necessary.  Requires light physical activity performing non-strenuous daily activities.