Principal Engineer (Electrical)

Ivenix, Inc.; Pennsylvania; On-site; USD 100,000 - 120,000; Full time

Job summary

Ivenix, Inc. is seeking a Principal Engineer (Electrical) in Warrendale, PA to lead life-cycle engineering for on-market medical devices, software, and lab equipment.

You’ll maintain design requirements, conduct testing, and support verification/validation while collaborating with manufacturing, quality, regulatory, and R&D teams. The role emphasizes solving complex electrical problems, driving automated testing tools, and leading investigations to ensure reliable and safe product performance in

Qualifications

• Bachelor's degree in Electrical Engineering with 5–7 years of relevant experience in automated test fixtures.
• Proficiency in automation and data analysis software, like Python, LabVIEW, and MATLAB.
• Experience troubleshooting hardware and software issues in a production environment.
• Experience with electrical design tools: Altium, PSpice, oscilloscopes, etc.
• Familiar with FDA QSR and ISO regulations: IEC 60601, design controls, document controls, design verification and validation.
• Able to manage projects, coordinate contractors, and direct the activities of a technician.

Responsibilities

• Engineer with Purpose – Drive design, development, integration testing, and RCA of complex electronic systems.
• Solve Real-World Problems – Apply engineering principles and tools to tackle technical challenges and ensure quality.
• Advance Automation – Design, deploy, and improve smart automation tools for production of medical devices.
• Design for Innovation – Develop custom test fixtures and hardware for validation and manufacturing.
• Lead Critical Investigations – Own in-depth failure analysis for field and production issues, including component faults and EMI.
• Ensure Continuity and Compliance – Evaluate supplier changes, assess part obsolescence, and lead requalification efforts.
• Be the Voice of the Customer – Analyze field returns, address complaints, contribute to CAPA activities.

Skills

Automation

Data analysis

Problem solving

Project management

Communication

Education

Bachelor's degree in Electrical Engineering

Tools

Altium

PSpice

Oscilloscopes

Signal generators

Python

LabVIEW

MATLAB

Job description

## Principal Engineer (Electrical)Applylocations: Warrendale, PA: Pennsylvaniatime type: Full timeposted on: Posted Todayjob requisition id: R-01021353# # **Job Summary**Salary Range: $100,000 to $120,000 Per Year dependent upon education and experience. Please note: This position cannot provide employment-based immigration sponsorship now or in the future. Applicants must be currently authorized to work in the United States for any employer and must be able to maintain that authorization for the entire duration of employment without requiring employer sponsorship at any time, including in the instance when your current work authorization expires. We ask that candidates answer all work authorization questions fully and accurately during the application process. The Principal Engineer performs Electrical Engineering tasks for the life-cycle management for on-market products manufactured at the production unit of active and non-active hardware medical devices, software, and laboratory equipment. This includes maintaining design requirements, design specifications, and risk management documentation; performing electrical testing; supporting verification and validation activities. This also includes performing technical and problem-solving activities to analyze and resolve field and manufacturing product issues. Requires working in a team environment with cross-functional team members, such as manufacturing, quality, regulatory, and other R&D departments.# # **Responsibilities**# 1) **Engineer with Purpose** – Drive the design, development, integration testing, and root cause analysis of complex electronic systems to meet critical product requirements and business goals.2) **Solve Real-World Problems** – Apply sound engineering principles, computational tools, and creative problem-solving to tackle technical challenges and ensure quality across the product life cycle.3) **Advance Automation** – Collaborate on the design, deployment, and continuous improvement of smart automation tools that power the production of cutting-edge medical devices.4) **Design for Innovation** – Work with cross-functional teams to develop custom test fixtures and specialized hardware to support product validation and manufacturing.5) **Lead Critical Investigations** – Take ownership of in-depth failure analysis for field and production issues, including component faults, ESD, soldering, and EMI.6) **Ensure Continuity and Compliance** – Evaluate supplier changes, assess part obsolescence, and lead requalification efforts for electrical components.7) **Be the Voice of the Customer** – Analyze field return data, address customer complaints, and contribute to CAPA activities to ensure reliable and safe product performance.***All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.*****REQUIREMENTS*** The Company’s primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.* Bachelors degree in Electrical Engineering and/or Engineering degree with 5-7 years of relevant experience in automated test fixtures.* Proficiency in automation and data analysis software, like Python, LabView, and Matlab* Experience with troubleshooting hardware and software issues in a production environment* Diagnose and resolve failures: PCBs, connectors, cables, sensors, batteries, power management circuits.* Experience with electrical design tools: Altium, Pspice, oscilloscopes, signal generators, etc...* Familiar with appropriate FDA QSR and ISO regulations: IEC 60601, design controls, document controls, design verification and validation.* Must possess a firm foundation in the basic principles of their respective engineering discipline.* Able to manage projects, coordinate contractors, and direct the activities of a technician.* Excellent verbal and written communication skills.# # **Additional Information**We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‐will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.