Electrical Engineer

The Electrical Engineer is responsible for supporting and sustaining existing product lines while ensuring high standards of manufacturing performance, product quality, and regulatory compliance. This position contributes to the development of new products and manufacturing processes, focusing on efficiency, reliability, and adherence to all applicable industry standards and guidelines.

Key responsibilities include maintaining current medical device product lines by identifying and replacing end‑of‑life components, collaborating with vendors to resolve quality concerns, qualifying second‑source components, and partnering with internal teams or external consultants on complex engineering initiatives. Sustaining activities also include, but are not limited to, developing and executing test protocols, analyzing technical and production data, updating engineering drawings, and maintaining software and technical documentation.

Essential Functions:

• Electro-Mechanical Product: Experience in electro-mechanical product assembly required with a demonstratable background in problem solving (debug, root cause analysis and corrective action).
• Legacy Product Support: Lead sustaining engineering activities for legacy medical device products.
• Obsolescence Management: Investigate, identify, and resolve electrical component obsolescence by sourcing alternatives or redesigning circuits/sub-assemblies.
• Design Changes & ECOs: Support design changes, including schematic updates, PCB layout modifications, and firmware updates (ECO process).
• Verification & Validation (V&V): Plan and execute V&V testing for design changes, ensuring compliance with medical safety standards (IEC 60601).
• Regulatory Compliance & DHF: Maintain Design History Files (DHF) and ensure documentation (BOMs, schematics, protocols) is accurate, current, and FDA, ISO and IEC compliant. Experience in a regulated industry (FDA, ISO, IEC, medical device, etc.) is helpful.
• Cross-Functional Collaboration: Collaborate with manufacturing, quality, supply chain, and regulatory teams to ensure product reliability.
• Field Issue Resolution: Troubleshoot and resolve technical issues reported by customers or field service teams.
• Engineering Software Tools: Experience with engineering software tools is a plus (LabVIEW, C++, Python, MATLAB).

• Electrical Test Equipment: Use electrical test equipment such as Oscilloscopes, Function Generators, Spectrum Analyzers etc. to debug problems with product and test equipment.
• All other duties as assigned.

Continuous Improvement Duties

• Troubleshoot problems within the various production lines related to assembly and testing processes and bring them to resolution using continuous improvement tools such as the A3 process and other root cause analysis tools.

• Actively participate in the implementation and monitoring of statistical process control techniques, including control chart development, application and identification of required support tooling or equipment.

• Support/Own NCs (Non-Conformances) and CAPAs (Corrective Action / Preventive Action) that require higher level technical skill to investigate and resolve, as needed.

• Own or engage with Operational Excellence tools at a Site level rolling up to Company level.

• Own or engage in sustained learning of Continuous Improvement with tools such as Spaghetti Diagram, 5S, Root Cause Analysis, Production Flow and others.

• Own or engage in various Site-specific Employee Engagement Processes such as: On The Spot, Fix It Ticket and others.

Education: 

• High school diploma or GED required.
• Associate’s or Bachelor’s Degree in Electrical Engineering, Electronics Engineering, Electro Mechanical Engineering  or related field required.

Electrical Engineer I

• 0- 3+ years engineering experience; experience with medical device troubleshooting or sustaining support preferred.

Electrical Engineer II

• 6+ years engineering experience; experience supporting regulated medical devices is preferred.

Electrical Engineer III

• 12+ years engineering experience in regulated medical devices; experience leading sustaining engineering efforts strongly preferred. Prior supervisory or technical leadership experience is a plus.

Key Required Skills, Knowledge and Capabilities:

• Strong computer skills with knowledge of Microsoft Office Suite (Word, Excel, OneNote and PowerPoint), e-mail and Internet.
• Excellent communication skills – written and verbal.
• Interpersonal skills to include customer-focused orientation with both internal and external customers.
• Strong decision-making skills, ability to work independently with minimal supervision.
• Comprehensive organization and analytical skills
• Project management experience a plus.
• Experience with continuous improvement teams, lean manufacturing, etc. preferred.