Description

JOB PURPOSE:

To design new devices/components and make design changes or improvements to existing devices/components. Supports projects as extended team member to bring new designs or design changes through the applicable phases of the Product Development Process.

ESSENTIAL DUTIES:

Functions as Extended Team member on project team

Follows through on assigned project activities through the applicable project phases to reach the final phase of Commercial Release for ongoing production

Understands and follows procedure for elements of project execution to meet the requirements of the Product Development Process

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

Utilizes engineering skills to optimize design and technology to drive innovation and significantly improve patient outcome

Considers all applicable aspects of product design including design for manufacturability, scalability, testing, variability, and usability

Establishes product requirements and design inputs based on the applicable standards as well as other relevant sources, such as Post-Market Surveillance

Provides detailed sub-assembly and final assembly drawings to serve as design specifications for a medical device

Develops protocols, test methods, and reports for execution of design verification and validation testing

Clearly depicts connection between product requirements, design inputs, design outputs, and verification/validation in traceability matrix

Participates in 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

Completes project activities for Commercial Release of product and corresponding manufacturing processes while meeting expectations for sustainable, efficient, repeatable, and reproducible manufacturing operations

Provides basic support on request for quotes by providing insight into project activities needed for new product introduction

Works with other members of the engineering team to ensure that project phases are completed in a timely manner

Upholds Spectrum Plastics Group vision and core values

Follows all safety guidelines and adheres to safety absolutes

Qualifications

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities)
Required:
•    Bachelor’s degree in engineering or equivalent experience in a related field
•    Ability to execute commonly-used concepts, practices, and procedures within  medical device design and development
•    Ability to problem solve, identify errors and deficiencies and perform research with general guidance
•    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 follow oral and written instructions

Preferred:
•    Understands Gantt Charts from programs such as Microsoft Project
•    Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2)

WORKING CONDITIONS: 
Works under supervision of both the manager and project leaders.  Requires light physical activity performing non-strenuous daily activities
 

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