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.