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
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.