Electrical Engineer Location: 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:
1. Schematic design, PCB layout, FPGA utilization, part selection and ordering, reviewing of drawings, software programming and validation, power distribution design and hardware testing
2. Assist in new product development projects and cost-reduction design activities
3. Co-lead (with mechanical and software team members) project development from electronic perspective.
4. Establish and implement validation requirements for products, test methods and manufacturing processes
5. Write software validation protocols and reports for new and revised software applications
6. Write process validation protocols and reports for new and improved manufacturing processes
7. Work directly with customers, marketing, sub-contracted manufacturers, vendors and other engineering disciplines in the development and application of products and systems
8. Create and maintain FDA compliant Design History Files (DHF)
9. Provide root cause analysis support and drive the implementation of corrective action for process-related issues
10. Execute process improvements as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485
11. Participate in complaint investigations, and failure analysis of products
12. Lead or participates in activities related to non-conformances and corrective and preventive actions (CAPA support) and complaints
13. Provide support for continuous improvement of the quality management system
14. Create inspection processes for each individual item within the design assignment
Requirements:
15. Minimum of a Bachelor of Science in electrical engineering
16. Minimum of four years of experience with schematic design and PCB layout using OrCAD or Altium Designer
17. Preferred familiarity with the medical device electrical safety & EMC requirements (IEC60601-1), regulatory (FDA & MDD) and Quality (QSR & ISO 13485) issues or similarly regulated industry
18. Experience working within a company’s Quality System is preferred
19. Experience with software programming, design specifications & requirements and verification & validation
20. Experience with electro-optical and mechanical medical devices is preferred.
21. Previously demonstrated project management skills
22. Ability to work effectively in a team environment and build strong working relationships
23. Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
24. Excellent organizational skills and attention to detail
25. Strong communication skills, both oral and written
26. Ability to prioritize, multi-task and adapt to change
27. High degree of initiative and self-motivation with a strong sense of accountability
28. This position requires 15% travel
Keywords: Electrical Engineer, BSEE, PCB Layout, OrCad, Altium Designer, IEC60601-1, FDA, MDD, QSR, ISO 13485 How to Express Interest - Click the Apply button and follow the online instructions.