Sr. Electrical Engineer
Medical Device Manufacturing
Shift: Multiple Shifts Available
Salary: $115,000-$155,000 p/y
Start Date: ASAP
We are seeking an experienced Senior Electrical Engineer II to join our rapidly growing product development team. This role is ideal for an engineer with extensive medical device design and development experience who can lead complex electrical engineering projects from concept through commercialization. The successful candidate will possess strong technical expertise, project leadership skills, and the ability to manage multiple priorities in a fast-paced, regulated environment.
Key Responsibilities:
- Lead the design, development, prototyping, testing, and release of electrical and electronic systems for Class II and Class III medical devices.
- Design and support analog, digital, embedded control, power management, and PCB-based electronic systems from concept through manufacturing.
- Develop next-generation medical device technologies, including prototype development, laboratory testing, and pre-clinical evaluation.
- Plan and lead engineering projects, managing project scope, schedules, budgets, milestones, and technical deliverables.
- Execute and document design verification, validation, risk analysis, and engineering testing in accordance with regulatory requirements.
- Develop product specifications, electrical schematics, PCB layouts, Bills of Materials (BOMs), Engineering Change Orders (ECOs), and manufacturing documentation.
- Participate in architecture development, hardware selection, design reviews, and design-for-manufacturing (DFM/DFA) activities.
- Collaborate with cross-functional teams including Program Management, Quality, Manufacturing, Regulatory Affairs, and external partners.
- Provide technical leadership, mentor junior engineers, and support engineering performance, development, and training.
- Support customer interactions, proposal development, project scoping, budgeting, and technical presentations.
- Drive continuous improvement initiatives while ensuring compliance with the company's Quality Management System (QMS) and applicable regulatory standards.
Required Qualifications:
- Bachelor's Degree in Electrical Engineering (Master's preferred).
- 8+ years of electrical engineering experience with a strong focus on medical device development.
- Proven experience designing complex analog, digital, embedded, and low-power electronic systems.
- Experience with PCB design, schematic capture, layout, design verification, and hardware validation (Altium Designer preferred).
- Strong understanding of signal integrity, noise reduction, power management, and embedded hardware design.
- Experience integrating Bluetooth, Bluetooth Low Energy (BLE), Wi-Fi, and NFC communication technologies.
- Experience developing PCB test fixtures, verification protocols, and manufacturing test methods.
- Proficiency with C, MATLAB, and LabVIEW.
- Strong project management, analytical, problem-solving, and communication skills.
- Ability to manage multiple technical projects while meeting aggressive deadlines.
Preferred Qualifications:
- Experience with flex circuit design.
- Experience working with OEMs, contract manufacturers, and external design partners.
- Successful participation in FDA 510(k), De Novo, CE Mark, or similar medical device regulatory submissions.
- Experience developing products incorporating biometric or physiological sensors.
- Working knowledge of ISO 13485, ISO 14971, ISO 62304, ISO 60601, and FDA Quality System Regulations (QSR).
- Experience using Jira, Bitbucket, and Confluence.
INDUS
Pay: $115,000.00 - $155,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Application Question(s):
- BS in Electrical Engineering (MS preferred)
Experience:
- Medical Device Product Development (Class II/III Devices): 6 years (Preferred)
- Analog & Digital Circuit Design: 6 years (Preferred)
- PCB Design & Layout (Altium Designer Preferred): 6 years (Preferred)
- Embedded Systems & PLC/Microcontroller Programming: 6 years (Preferred)
- Design Verification & Validation (V&V) in ReFDA: 6 years (Preferred)
- ISO-gulated Environments: 6 years (Preferred)
- Project Leadership / Technical Project Management: 6 years (Preferred)
- Biometric and Physiological sensors: 6 years (Preferred)
Work Location: In person
