This is an onsite position requiring the team member to be onsite 5 days a week. No relocation is provided for this opportunityJob SummaryIn this role, you will be responsible for Sustainment Engineering tasks for the company's electromechanical wearable drug delivery devices, as part of the global HW & SW R&D group. As a highly motivated and detail-oriented Sustainment Engineer you will work autonomously to support ongoing engineering activities through active programs and general product sustainment, with remote guidance and support, as needed. This role is critical in ensuring product reliability, regulatory compliance, and continuous improvement through structured problem-solving and cross-functional collaboration.
Essential Duties and Responsibilities- Lead device investigations for new and existing devices, solve complex problems.
- Implement corrective actions related to: Non-Conformance Reports (NCRs), Supplier Corrective Action Requests (SCARs), Customer complaints.
- Manage and document PCBA component or material changes, ensuring traceability and compliance.
- Support change impact assessments across engineering, manufacturing, and quality domains.
- Facilitate change controls for Software and Hardware changes, create and support project documentation.
- Support customer interactions to demonstrate system performance.
- Support risk assessments, FMEA/dFMEA and design reviews.
- Support project scoping activities, including time, cost, and resource estimation for new customer programs or development initiatives.
- Other duties as assigned.
Education- Bachelor's Degree in Electrical Engineering or equivalent experience is required
Work Experience- 5+ years of experience in product sustainment or R&D support.
- Experience and knowledge of root cause analysis methodologies (e.g., FMEA, FTA, Fishbone).
- Familiarity with PCBA design and manufacturing processes.
- Proficient with electronic CAD tools (Altium and/or OrCad) and Microsoft Office products.
- Ability to read electronic schematic and work with Oscilloscope and other electronic lab equipment.
Preferred Knowledge, Skills and Abilities- Advanced degree preferred.
- 10+ years of experience in product sustainment or R&D support.
- Multidisciplinary knowledge of electronics and software.
- Working knowledge of regulatory standards (e.g., ISO 13485, FDA, IEC).
- Experience with QMS tools and change control systems.
- Knowledge of C/C++ languages and programing using Embedded C for various SoCs / Microcontrollers in the market is preferred.
- Experience in a highly regulated industry (e.g., medical devices, aerospace, automotive).
- Experience with Change control and impact assessments.
- Experience with microcontroller architecture, digital circuit design and various communication protocols such as I2C, UART, BLE, USB etc.
- Demonstrated ability to work cross-functionally and influence without authority.
- Experience with supporting medical electromechanical device throughout product lifecycle.
- Knowledge and experience with motor control.
- Knowledge of FDA Design Controls, Statistics, and Manufacturing is a plus.
- Experience with ARM architecture (32-bit).
- Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description.
- Cooperative, "Team Player", responsible, thorough, and committed to time lines, "go-getter". #LI-NJ1 #LI-Onsite
Travel Requirements5%: Up to 13 business days per year
Physical RequirementsSedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
