Entegee

Compensation

Full Description

100% onsite position for a top Medical Device company in Arden Hills, MN. • * BS Degree Engineering and 5+ years of exp • * Medical Device product development • * DFMEA, Design Failure Modes, Design V&V, Test Method Validation (TMV) and Design Transfer • * Technical Writing • * ISO 13485/14971 • * CAPA Minimum requirements: • Bachelor's degree in an engineering or related discipline with 5+ years of relevant experience • Experience in Medical Device industry; Knowledgeable in Quality System Regulations, Medical Device Regulation, ISO 14971 and ISO 13485 Quality Standards with a focus on design controls and design optimization. • Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook. • Ability to collaborate and influence across multiple, cross-functional teams • Demonstrated technical problem-solving & data analysis capabilities Preferred Qualifications: • Experience in design engineering or process development, including test method validation, process validation, and continuation engineering. • Experience writing specifications, test protocols, and technical reports. • Demonstrated use of Quality tools and methodologies including DFMEA, DOE, Brainstorming, Root Cause Analysis, and 5 Why’s. • Experience in post-market quality, including returned product analysis and corrective and preventative action (CAPA). • Experience with Class III Medical Devices, including Electrical Medical Equipment (EME) or Active Implantable Medical Devices (AIMD). • Adaptable and effective collaborator in a team environment or in self-directed work. • Strong ability to successfully multi-task and demonstrate adaptability • Strong communications skills. Effectively present complicated technical information to small and large audiences, from peers to senior leadership, with varying levels of technical expertise Responsibilities include: • Understanding and application of design engineering concepts and tools including Design Failure Modes and Effects Analysis (DFMEA), Design Verification & Validation, Benchmarking, Test Method Validation, and Design Transfer. • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues including CAPA work. • Review and approve quality records, including product specifications, design verification test protocols, and design verification test reports. • May lead or contribute to collaborative problem solving of complex technical issues using disciplined, methodical techniques. Tools used include DMAIC, Root Cause Analysis, 5 Whys, Cause & Effect Diagram, and Is-Is Not. • Creates, maintains, and enhances cross-functional team partnerships. Provides guidance regarding technical strategies and approaches; works cross-functionally and across multiple sites in identifying and resolving technical issues. • Focuses on continuous improvement by championing and fostering the execution of projects within the local and divisional Design Assurance organizations. • Fosters a diverse and inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives. • Monitors and ensures compliance with company policies and procedures. • Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Job Disclaimer: Equal Opportunity Employer/Veterans/Disabled Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/ The Company will consider qualified applicants with arrest and conviction records. #GRPC Job Types: Full-time, Contract Pay: $45.00 - $55.00 per hour Expected hours: 40 per week Work Location: In person