Product Development Engineer II
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 (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.
Recommended Skills Attention To Detail Communication Design And Technology Design For Manufacturability (Industrial Design) Finance Health Care Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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 (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.
Recommended Skills Attention To Detail Communication Design And Technology Design For Manufacturability (Industrial Design) Finance Health Care Apply to this job.
Think you're the perfect candidate? Apply on company site Estimated Salary: $20 to $28 per hour based on qualifications.
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