ARM (Advanced RISC Machine), Aerospace and Defense, C Programming Language, C++ Programming Language, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Change Control, Communications Protocols, Compensation and Benefits, Continuous Improvement, Control Systems, Corporate Policies, Corrective Action, Cost Estimates, Cross-Functional, Customer Relations, Customer Support/Service, Design Failure Mode and Effects Analysis (DFMEA), Detail Oriented, Digital Circuit Design, Diversity, Document Management, Drug Delivery Devices, Electrical Engineering, Electromechanics, Electronics, Embedded Systems, FDA (Food and Drug Administration), Failure Mode and Effects Analysis (FMEA), Government, Healthcare, I2C, ISO (International Organization for Standardization), International Electro-Technical Commission (IEC), Laboratory Equipment, Maintain Compliance, Manufacturing, Manufacturing/Industrial Processes, Medical Equipment, Medical Products, Microcontroller, Microsoft Office, Microsoft Product Family, Motor Control Systems, OrCAD, Oscilloscope, Patient Care, Printed Circuit Board Assembly (PCBA), Problem Solving Skills, Product Lifecycle, Regulations, Regulatory Compliance, Research & Development (R&D), Risk Analysis, Root Cause Analysis, Safety/Work Safety, Schematics, Standard Operating Procedures (SOP), Statistics, Support Documentation, Sustainability, Team Player, Traceability, USB, Universal Asynchronous Receiver-Transmitter (UART), Volunteer Experience, Willing to Travel
This is an onsite position requiring the team member to be onsite 5 days a week.
No relocation is provided for this opportunity
Who We Are:
At West, we're a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West's indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?
There's no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.
We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.
What We Offer
Generous Paid Time Off (PTO): Flexible vacation, personal, and holiday leave ensures employees can maintain a healthy work-life balance and recharge effectively.
Community Involvement: West encourages volunteerism through its West without Borders initiative and other charitable programs that make a difference in local communities.
Inclusive & Collaborative Culture: A global workforce that values diversity, equity, and inclusion-where all voices are heard and respected in a supportive environment.
Job Summary
In 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
- Bachelors 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 Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-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.
West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status. If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com. Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.
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West Pharmaceutical Services Inc
Leadership in Drug Administration Systems and Components Pharmaceutical, biopharmaceutical and medical device companies around the world rely on West Pharmaceutical Services, Inc. for standard-setting systems and device components for parenterally administered medicines.
West applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of
pharmaceuticals, biologics, vaccines and consumer healthcare products.