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:

• Bachelor’s degree in engineering or equivalent experience in a related field.
• 7+ years industry experience
• Proficient in commonly-used concepts, practices, and procedures within medical device design and development
• 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
• Can handle financial responsibilities for major programs, such as budget accountability and revenue recognition
• 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 apply knowledge to their job function using pre-established guidelines and instructions
• 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
• Proficiency in Microsoft Project
• Demonstrated ability to complete product design transfers
• Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)

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.