Product Development Engineer

Spectrum Plastics Group

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 SPG and Dupont vision and core values
Performs all other duties as assigned

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
Responsible for understanding and complying with all SPG and DuPont safety policies and procedures

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.

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Vacancy posted 2 days ago

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