Sr Principal Engineer

Fresenius Kabi•North Andover, MA

1d•Hybrid

About The Position

The Senior Principal Engineer works without direct supervision on complex engineering problems and leads the definition of electrical architecture for Fresenius Kabi infusion devices. The role leads the design, development, and enhancement of electrical systems and products to achieve performance goals and business objectives, applying advanced engineering practices to problems of high complexity. It leads projects and may supervise or direct lower-level engineers on assigned work. The engineer designs analog, digital, mixed-signal, and power circuits; investigates new technologies and best practices; and troubleshoots equipment and complex systems. The role participates throughout the product lifecycle, including development, verification, new product introduction, and post-market support. It also develops innovative solutions, evaluates results against product requirements and program goals, establishes engineering documentation best practices, and advises senior management. The position assesses risks, develops and conducts risk-prioritized test plans, analyzes results and residual risks, and evaluates whether test evidence supports conclusions. It applies regulations, guidance, and standards to design verification and validation activities and prepares documentation in accordance with standard operating procedures. The role collaborates across disciplines and with senior internal and external personnel, and provides technical advice and assistance to team members. This is a hybrid role requiring onsite work three days per week. The listed salary range is $145,000–$155,000, with eligibility to participate in a bonus plan targeting 10% of base salary. Applicants must be authorized to work for any U.S. employer; Fresenius Kabi cannot sponsor or take over sponsorship of an employment visa.

Requirements

Bachelor’s degree in Engineering, Information Technology, or a related field is preferred.
Minimum 8 years of experience in an engineering team, troubleshooting, and problem solving.
Minimum 3 years of experience working within a regulated industry; medical industry experience preferred.
Expert knowledge of analog, mixed-signal, and power circuit design.
Experience and familiarity with standards governing medical electrical safety and electromagnetic compatibility, and activities necessary to achieve IEC 60601 certification.
Skill in writing design description documentation.
Experience with communication interfaces, including I2C, SPI, UART, Wi-Fi, and Bluetooth.
Experience with controls for stepper and/or BLDC motors, actuators, sensors, and data acquisition.
Familiarity with circuit simulation tools such as PSpice.
Experience with software tools including ORCAD Capture and Allegro PCB.
Experience with CAD tools, including schematic capture and PCB design.
Ability to work collaboratively as a team member and lead in an agile environment.
Ability to diagnose and solve problems involving multiple technologies, such as mechanical, electrical, and software systems.
Ability to train, mentor, and supervise test team personnel.
Expert analysis, troubleshooting, and debugging skills.
Attention to detail and a methodical, hands-on approach in a development lab environment.
Task-management skills and ability to prioritize multiple assignments.
Strong problem-solving and analytical skills.
Excellent written and verbal communication skills.

Nice To Haves

An advanced degree or certification is preferred.
Medical-industry experience is preferred.
May publish in journals and/or hold patents.

Responsibilities

Lead the definition of electrical architecture for Fresenius Kabi infusion devices.
Lead the design and development of products and processes relating to electrical architecture.
Design analog, digital, mixed-signal, and power circuits.
Investigate new technologies and best practices.
Troubleshoot equipment problems and perform complex system tests.
Participate in all phases of the product lifecycle, including development, verification, new product introduction, and post-market support.
Generate and implement innovative solutions to complex problems using multiple disciplines and technical principles.
Advise senior management regarding appropriate actions.
Establish best practices for engineering documentation within the electrical team.
Evaluate results against product requirements, definitions, and program goals.
Identify risks, requirements, architectural components, functions, and performance needs, and determine appropriate regression tests.
Assess risks, create risk-prioritized test plans, analyze test results, draw conclusions, and assess residual risks and the adequacy of supporting test evidence.
Apply regulations, guidance, and standards to design verification and validation activities, and prepare documentation for compliance with standard operating procedures.
Network with senior internal and external personnel and facilitate cross-functional teams.
Provide advice and assistance to team members on routine and unique problems.
May supervise or direct lower-level engineers on assigned projects.