Mechanical Engineer II

Job Title: Mechanical Engineer II Location: 600 Technology Drive, Newark, DE, 19702 Shift: 8am 5pm, Monday Friday Duration: 12+ Month(Possible extension/Conversion) Job Summary: Designs, implements and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing and managing compliance of manufacturing and production processes with internal and external safety, quality and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing and evaluating the precision and accuracy of production processes, production equipment and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May assure compliance to in-house and/or external specifications and standards (i.e. GLP, GMP, ISO, Six Sigma). Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Performs hands on troubleshooting of electro-mechanical medical devices to identify root causes to non-conformances that occur during the manufacturing processes. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is a fully qualified, career-oriented, journey-level position. Normally receives little instruction on day-to-day work, general instructions on new assignments. Essential Duties and Responsibilities: The incumbent may be asked to perform other function-related activities in addition to the below-mentioned responsibilities as reasonably required by business needs. Responsible for identifying, diagnosing, prioritizing, and correcting technical issues that may arise in standard manufacturing processes. Works in conjunction with other departments where appropriate. Evaluate and develop process control data for trending analysis. Analyzes defects, provides feedback, and implements process improvements. Participates in design reviews, working with R&D and manufacturing to resolve all issues, particularly those arising from the violation of design standards or changes from existing manufacturing procedures. Actively supports and adheres to the Quality Policy and Quality System procedures. Identify and lead complex projects that drive meaningful improvements positively impacting product quality and manufacturing efficiency and costs. Write & Execute and Coach Others on how to perform TMV’s Write & Execute and Coach Others on Complex Change Orders (Procedure updates, validations, clarifications, etc) Lead/Own Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOP’s/documents, etc) Write & Execute and Coach Others on how to perform PQ’s Lead/Own CAPA’s and HRA’s/HHE’s Model all quality values and coaches others on BSH quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement. Collaborate and communicate effectively with junior level employees, peers and cross-functional teams across all levels of the organization. Collaborates with Operations, Engineering and R&D Accountable for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations. Accountable for the development, training delivery and monitoring of procedures, investigation procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive requirements Acts with urgency to identify and lead the timely resolution of quality issues. Lead moderate to complex risk management, defect investigation, customer complaint investigation and corrective action activities. Leads quality projects and will provide cost, schedule and resource needs for assigned projects. Responsible for monitoring and providing regular communication and updates on success factors such as progress, schedule, budget, project risks and resource of needs gaps. Ensure data, protocols and reports meet project objectives. Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry. Collaborate with other engineers and promote learning, development and knowledge transfer. Mentors and coaches junior Engineering staff. Provides technical expertise for Non-Conformance Events risk assessments and planned deviations. Author technical protocols, technical reports, and complaint investigation reports. Responsible for processes such as QSI, MRB, NCE, CAPA and SCAR process. Responsible for the review and approval process for ECO s product related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification and validation documentation. Responsible compliance required facility and supplier audits and Notified Body and FDA inspections. Executes analysis of large datasets. Analyze associated lines of investigation and devise and recommend methods to resolve problems. May participate in external collaborations. May present results and progress for management and key external customer review. Identify and recommend improvements to the organization, processes, procedures and the Quality Management System. Physical Demands: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Lifting/moving and carrying products weighing up to 40 pounds. Exposure to moving mechanical parts, vibration and/or moderate noise levels. Exposure to hazardous chemicals or other materials. Safety Shoes with Impact and Compression Protection Must be worn in designated areas. Other (please specify): high voltage electronics, radiation. Ability to work in clean room, controlled environment, and/or dark room. Qualifications: Education Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree in Mechanical or Electrical Engineering Experience Preferred Minimum Technical/Advanced Degree: 2-5 Years with Technical Bachelor’s Degree, 1-3 Years with Master’s Degree, 0-1 Years with PhD Experience with cleanroom processes is beneficial. Experience troubleshooting mechanical or electrical medical devices is preferred. Skills Excellent computer skills including ability to use word processing, spreadsheet programs and databases Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations. Excellent technical writing skills with ability to write quality assurance reports and details procedures Good knowledge of microbiology, molecular biology, biochemistry, chemistry and/or related disciplines Good understanding of nucleic acid amplification and detection technologies Good understanding of Scientific Method and statistical analysis Ability to plan and supervise execution of projects, keep to timelines and prioritize resources Ability to troubleshoot and solve technical issues across multiple assays and platforms Ability to analyze data and come to valid scientific conclusions Ability to document technical work and lead investigations and improvements in a GMP environment Knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma Good technical writing skills and ability to prepare and present data Excellent collaboration and interpersonal skills Working knowledge of FDA and ISO regulations that govern the Medical Device is beneficial. Certified Quality Engineer is beneficia #J-18808-Ljbffr