Senior Principal Mechanical Engineer (Medical Devices)

Fresenius Kabi USA; Massachusetts; Hybrid; USD 165,000 - 175,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401(k) with company contribution

Wellness program

Hybrid work model

Job summary

Fresenius Kabi USA is seeking a Sr Principal Engineering (Mechanical) to lead the design and development of infusion hardware products. You will direct and implement mechanical system improvements to meet performance goals and business objectives, serving as the technical lead for durable goods and mentoring engineers.

The role requires 10+ years in mechanical design, experience in regulated environments, and strong proficiency with CAD and DFMEA.

Qualifications

• BS or MS in Mechanical Engineering or equivalent.
• 10+ years of experience as a mechanical design engineer on product development teams.
• 5+ years of experience in a regulated environment (Medical, Aerospace, Military).
• Experience designing complex electro-mechanical assemblies in SolidWorks or other CAD system.
• Experience selecting materials and fabrication methods based on engineering requirements.
• Experience using PDM to manage database and drawing revisions in accordance with FDA requirements.
• DFM or New Product Introduction experience.
• Experience with system integration challenges such as thermal management of electronics, machined and injection molded part design, and design for reliability.
• Attention to details and methodical, hands-on work in an R&D lab environment.
• Strong task management and prioritization skills.
• English proficiency per regulatory requirements.

Responsibilities

• Leads the design and development of Infusion products within the hardware team.
• Designs complex electro-mechanical mechanisms to achieve engineering performance goals.
• Establishes and performs DoE to assess and characterize new solutions and designs.
• Integrates functional elements into a unified system design.
• Designs product housings that integrate subsystems into an ergonomic industrial design.
• Generates GD&T drawings identifying critical dimensions per tolerances and manufacturing capabilities.
• Performs and leads DFMEA and updates designs accordingly.
• Optimizes designs for cost, quality, reliability and high-volume assembly.
• Investigates new technologies and best practices.
• Establishes best practices for engineering documentation within the mechanical team.
• Focuses design efforts on improved performance and reduced complexity.
• Coordinates with internal and external resources to conduct design, prototyping, and transfer to manufacturing.
• Performs and documents failure analysis of returned products to drive improvements.
• Works with customers and vendors on technical issues.
• Creates project timeliness and tracks progress to schedule.
• Health, Safety, Environment, Energy and Quality Management System compliance.

Skills

Mechanical design

Electro-mechanical assemblies

SolidWorks

DFMEA

DoE

DFM

System integration

Thermal management

GD&T

Engineering leadership

Education

BS in Mechanical Engineering

MS in Mechanical Engineering

Tools

PDM

SolidWorks

Job description

Fresenius Kabi USA is seeking a Sr Principal Engineering (Mechanical) to lead the design and development of infusion hardware products. You will direct and implement mechanical system improvements to meet performance goals and business objectives, serving as the technical lead for durable goods and mentoring engineers.

The role requires 10+ years in mechanical design, experience in regulated environments, and strong proficiency with CAD and DFMEA.