Share Email Opening Apply Now Title Product Engineer  EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description Scope of the Role To design new medical devices and make design changes or improvements to existing medical devices. Supports projects as core team member to bring new designs or design changes through the applicable phases of the Design Control Process. Duties and Responsibilities Functions as Core Team member on project team or serves as project leader for projects that are smaller in scope 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 Design Control 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   Position Requirements Qualifications Required: Applicable Bachelor’s degree in Engineering discipline Understands Gantt Charts from programs such as Microsoft Project Medical device background Knowledge of applicable standards for EtO sterilization (e.g. ANSI/AAMI/ISO 11135-1, ANSI/AAMI/ISO 11135-2) 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   Location SPG - Tucson, AZ   About the Organization Based in Alpharetta, Georgia with multiple plants across the United States, Mexico, Costa Rica, Ireland and Malaysia, Spectrum Plastics Group is a North American leader in the development and manufacture of specialty medical plastic products. Only Spectrum Plastics Group has the product breadth, expertise and global reach to deliver critical medical plastics at scale. We deliver operational excellence, innovative solutions and a high level of execution resulting in what our customers value most: precision, performance and repeatability. Spectrum Plastics Group offers a full range of custom design, engineering and fabrication services, as well as meets the requirements of ISO 9001, ISO 13485, FDA, operating multiple Class 7 & Class 8 clean rooms. When medical plastics are critical, the industry trusts us. Specialties: High performance extrusion Tight tolerance extrusion Extrusion Precision injection-molding Micro-molding Medical tubing PVC tubing Silicone Packaging Finished Devices/Assembly Contract manufacturing Clean room Thermoplastic tubing extrusion Medical device Medical plastics Medical components Microbore extrusion Bioabsorbables Catheters   This position is currently accepting applications. Apply Now Follow us See who works here:

 

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