Electrical Engineer

Electrical EngineerLocation:Malvern, PA (Hybrid, 4 days in office, 1 day work from home)Compensation:The compensation will consist of base salary commensurate with experience + Bonus potential based on the individual and company performance.Opportunity Summary:We are excited to be partnering with a growing medical device manufacturer in the Malvern, PA Area who is known for promoting work life balance and a family oriented work environment in their search for an Electrical Engineer. The Electrical Engineer (EE) is responsible for leading a project team in the electrical and software design and development. This position will also work closely with Quality Assurance including internal/external quality issue resolution, supplier quality issues, customer complaints, to drive process improvements. This is a hybrid role with 4 days in office, 1 day work from home.Job Duties:Schematic design, PCB layout, FPGA utilization, part selection and ordering, reviewing of drawings, software programming and validation, power distribution design and hardware testingAssist in new product development projects and cost-reduction design activitiesCo-lead (with mechanical and software team members) project development from electronic perspective.Establish and implement validation requirements for products, test methods and manufacturing processesWrite software validation protocols and reports for new and revised software applicationsWrite process validation protocols and reports for new and improved manufacturing processesWork directly with customers, marketing, sub-contracted manufacturers, vendors and other engineering disciplines in the development and application of products and systemsCreate and maintain FDA compliant Design History Files (DHF)Provide root cause analysis support and drive the implementation of corrective action for process-related issuesExecute process improvements as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485Participate in complaint investigations, and failure analysis of productsLead or participates in activities related to non-conformances and corrective and preventive actions (CAPA support) and complaintsProvide support for continuous improvement of the quality management systemCreate inspection processes for each individual item within the design assignmentRequirements:Minimum of a Bachelor of Science in electrical engineeringMinimum of four years of experience with schematic design and PCB layout using OrCAD or Altium DesignerPreferred familiarity with the medical device electrical safety & EMC requirements (IEC60601-1), regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industryExperience working within a company's Quality System is preferredExperience with software programming, design specifications & requirements and verification & validationExperience with electro-optical and mechanical medical devices is preferred.Previously demonstrated project management skillsAbility to work effectively in a team environment and build strong working relationshipsAbility to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidenceExcellent organizational skills and attention to detailStrong communication skills, both oral and writtenAbility to prioritize, multi-task and adapt to changeHigh degree of initiative and self-motivation with a strong sense of accountabilityThis position requires 15% travelKeywords: Electrical Engineer, BSEE, PCB Layout, OrCad, Altium Designer, IEC60601-1, FDA, MDD, QSR, ISO 13485