Electrical Engineer – Medical Device Sustaining & EOL (Design Controls)

Job Title: Electrical Engineer – Medical Device Sustaining & EOL (Design Controls)

Location: Batesville, IN 47006 (Hybrid | 3 Days Onsite / 2 Days Remote | First 1–2 weeks fully onsite)

Contract Duration: 2 Months Contract with possibility of Extension

Shift Structure: First Shift | Type 1 Shift (Standard Daytime Business Hours / 8:00 AM – 5:00 PM), Monday through Friday

Pay Rate: $50.00 - $55.00/hr on W2

Portfolio Requirement: N/A

Visa Sponsorship: Standard onshore onboarding requirements apply.

Job Description: Our client is a global leader in critical care technologies, hospital beds, smart patient monitoring, and connected health ecosystems, is seeking an experienced Electrical Engineer to join their R&D and Sustaining Engineering team in Batesville, IN. In this technical lead role, you will drive critical electronic End of Life (EOL) and component obsolescence redesign projects across existing medical electrical product lines. You will evaluate alternative components, modify circuit schematics and PCB designs, collaborate with component suppliers and external partners, lead verification testing, and maintain rigorous Design History Files (DHF) in compliance with FDA 21 CFR 820.30 and IEC 60601-1 standards.

Key Responsibilities:

• EOL & Obsolescence Engineering: Serve as the technical lead on component obsolescence/EOL initiatives, evaluating replacement ICs, microcontrollers, and passives while safeguarding device safety and functionality.
• Circuit Design & Schematic Updates: Execute board-level engineering changes, update electrical schematics, and collaborate with layout resources to implement replacement components.
• Design Controls Compliance: Generate and update design control documentation compliant with FDA 21 CFR 820.30 and ISO quality standards, including Engineering Change Orders (ECOs), risk analyses, and DHF updates.
• Verification Protocol & Testing: Define verification test strategies, build test setups, and execute bench testing to demonstrate compliance with IEC 60601-1 (Medical Electrical Equipment Safety & Essential Performance).
• Supplier & Cross-Functional Alignment: Partner closely with component suppliers, contract manufacturers, embedded firmware engineers, and plant operations to ensure smooth implementation of updated designs.
• Root Cause & Statistical Engineering: Apply structured engineering methodologies (Design of Experiments [DOE], Statistical Process Control [SPC], failure analysis) to troubleshoot circuit performance anomalies.

Required Qualifications & Skills:

• Experience Level: 5 to 10 years of hardware/electrical engineering experience in a design, development, or sustaining capacity within the medical device industry.
• Medical Design Controls: Deep working knowledge and hands-on application of design controls (FDA 21 CFR 820.30 and ISO 13485 / ISO 9001).
• Safety & Regulatory Compliance: Working knowledge of IEC 60601-1 general requirements for medical electrical equipment safety and essential performance.
• Embedded Hardware Acumen: Demonstrated background designing, debugging, and verifying electronic medical equipment integrating embedded firmware.
• Schedule & Physical Requirements: Ability to maintain a hybrid schedule (3 days onsite in Batesville, IN, with the first 1–2 weeks 100% onsite) and periodically lift test fixtures up to 35 lbs.
• Education: Bachelor’s degree in Electrical Engineering (BSEE), Electronic Engineering Technology, or a related engineering discipline.

Stand-Out Skills (Preferred):

• Track record executing component EOL, obsolescence redesigns, or second-sourcing qualification for active medical devices.
• Prior exposure supporting EU MDR technical documentation remediation.
• Operational experience supporting the transition between New Product Development (NPD) and sustaining plant production.
• Hands-on proficiency with mixed-signal circuit simulation, bench test automation, and power supply design.

Actual Skills Required:

1. Electrical Component EOL / Obsolescence Engineering & Schematic Redesign
2. Medical Device Design Controls Compliance (FDA 21 CFR 820.30 & ISO 13485)
3. Medical Electrical Safety Standards (IEC 60601-1)
4. Hardware Verification Protocol Authoring & Bench Testing
5. Supplier Coordination & Cross-Functional Project Leadership

Recruiter Email ID: jevin@cube-hub.com