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Electrical Engineer

Gables Search Group

Malvern, PA

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JOB DETAILS
LOCATION
Malvern, PA
POSTED
5 days ago
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:
  • 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
How to Express Interest - Click the Apply button and follow the online instructions.

About the Company

G

Gables Search Group

Gables Search Group headquartered in Cleveland, Ohio has been a leader in search and placement nationwide since 2002.  Our company specializes in both direct and contract (temporary) staffing in all industries and disciplines.

At Gables Search Group, we connect exceptional professionals with outstanding organizations.  Our commitment to integrity, excellence, partnership, innovation, and respect sets us apart. With a personalized approach to recruitment, we ensure the perfect match between candidates and employers.

Whether you are a talented professional seeking new opportunities or an organization looking to build a high-performing team, Gables Search Group is here to guide you through the journey. Our success is built on the success of our clients and candidates, and we are dedicated to making a positive impact on the careers and businesses we serve.

COMPANY SIZE
50 to 99 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2002
WEBSITE
https://www.gablessearch.com/