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:

• Schematic design, PCB layout, FPGA utilization, part selection and ordering, reviewing of drawings, software programming and validation, power distribution design and hardware testing
• Assist in new product development projects and cost-reduction design activities 
• Co-lead (with mechanical and software team members) project development from electronic perspective.
• Establish and implement validation requirements for products, test methods and manufacturing processes 
• Write software validation protocols and reports for new and revised software applications 
• Write process validation protocols and reports for new and improved manufacturing processes 
• Work directly with customers, marketing, sub-contracted manufacturers, vendors and other engineering disciplines in the development and application of products and systems
• Create and maintain FDA compliant Design History Files (DHF) 
• Provide root cause analysis support and drive the implementation of corrective action for process-related issues 
• Execute process improvements as they relate to quality system compliance with FDA 510(K), QSR and ISO 13485 
• Participate in complaint investigations, and failure analysis of products 
• Lead or participates in activities related to non-conformances and corrective and preventive actions (CAPA support) and complaints 
• Provide support for continuous improvement of the quality management system
• Create inspection processes for each individual item within the design assignment
   

Requirements:

• Minimum of a Bachelor of Science in electrical engineering
• Minimum of four years of experience with schematic design and PCB layout using OrCAD or Altium Designer
• 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
• Experience working within a company’s Quality System is preferred
• Experience with software programming, design specifications & requirements and verification & validation
• Experience with electro-optical and mechanical medical devices is preferred.
• Previously demonstrated project management skills
• Ability to work effectively in a team environment and build strong working relationships
• Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
• Excellent organizational skills and attention to detail
• Strong communication skills, both oral and written
• Ability to prioritize, multi-task and adapt to change
• High degree of initiative and self-motivation with a strong sense of accountability 
• This position requires 15% travel

Keywords: Electrical Engineer, BSEE, PCB Layout, OrCad, Altium Designer, IEC60601-1, FDA, MDD, QSR, ISO 13485