Engineering Specialist (Mechanical)

RXinsider LTD.; Massachusetts; Hybrid; USD 165,000 - 175,000; Full time

Benefits offered by this job

401(k) with company contributions

Health benefits

Paid vacation and holidays

Personal days

Job summary

Fresenius Kabi is seeking an Engineering Specialist to lead mechanical design for infusion products. You will direct development, perform complex electro-mechanical designs, and drive DoE and DFMEA efforts to meet performance goals.

The role requires 10+ years in mechanical design, with experience in regulated environments and CAD systems. This hybrid position offers a competitive salary and benefits with on-site days three per week.

Qualifications

• BS or MS in Mechanical Engineering is required.
• 10+ years of mechanical design experience on product development teams.
• 5+ years in a regulated environment (Medical, Aerospace, Military).
• Experience designing electro-mechanical assemblies in CAD.
• Experience selecting materials and fabrication methods.
• Experience using PDM to manage drawings per FDA requirements.
• DFM or NPI experience.
• System integration challenges including thermal management.
• Detail-oriented with methodical, hands-on approach.
• Strong task management and problem solving abilities.

Responsibilities

• Leads design and development of Infusion products within the hardware team.
• Designs complex electro-mechanical mechanisms to meet performance goals.
• Establishes and performs DoE to assess new solutions.
• Integrates functional elements into a unified system design.
• Designs product housings that integrate subsystems.
• Generates GD&T drawings per tolerance analysis and capabilities.
• Performs DFMEA and updates designs accordingly.
• Optimizes designs for cost, quality, reliability, and high-volume assembly.
• Investigates new technologies and best practices.
• Establishes engineering documentation best practices.
• Coordinates with internal/external resources for design, prototype, transfer to manufacturing.
• Performs failure analysis and drives product improvements.
• Collaborates with customers and vendors on technical issues.
• Creates project timeliness and tracks progress to schedule.
• Ensures compliance with Health, Safety, Environment, and Quality policies.

Skills

Mechanical design

Regulated environment

SolidWorks

PDM experience

DFM / NPI

Thermal management

Detail-oriented

Project management

Problem solving

Education

BS or MS in Mechanical Engineering

Tools

SolidWorks

PDM

Job description

Job Summary

The Engineering Specialist is a self-starter who can play a principal role in our development team. In this role you will plan, direct and implement the designs and improvements to the mechanical systems in Fresenius-Kabi products to achieve product performance goals and business objectives. This position is the technical lead for the development and ongoing support of all durable goods designed by Fresenius-Kabi. Mentors and guides experienced engineers and leads team projects.

Salary Range: $165,000 - $175,000 based on experience

• Position is eligible to participate in a bonus plan with a target of 15% of the base salary (include only if applicable to the grade level)


• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.


• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Hybrid role: Onsite 3 days per week

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.

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 unto a unified system design.

Designs product housings that integrate subsystems into a sleek, ergonomic industrial design.

Generates GD&T drawings identifying critical dimensions according to tolerance stack up analysis and manufacturing process capabilities.

Performs and leads DFMEA according to product / system functional analysis, and updates designs (3D and 2D) and solutions accordingly.

Optimizes designs for low-cost, high quality, high reliability and high-volume assembly.

Investigates new technologies and best practices.

Establishes best practices for engineering documentation within the mechanical team.

Focuses design efforts around improved performance and reduced complexity.

Coordinates with internal and external resources to conduct design, redesign, prototype, and transfer to manufacturing activities.

Performs and documents failure analysis of returned product to drive product improvements.

Works with customers and vendors as needed regarding technical issues.

Creates project timeliness for mechanical engineering activities and tracks progress to the schedule.

All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities.

Requirements

The requirements listed below are representative of the knowledge, skill, and /or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• BS or MS in Mechanical Engineering.


• 10+ years of experience as a mechanical design engineer on product development teams.


• 5+ years of experience developing within a regulated environment (Medical, Aerospace, Military).


• Experience designing complex electro-mechanical assemblies in SolidWorks or other CAD system.


• Experience in selecting appropriate materials and fabrication methods based on engineering requirements.


• Experience using PDM to manage database and drawing revisions in accordance with FDA requirements.


• Design for Manufacturing (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, natural inclination to be methodical and hands‑on in a R&D lab environment.


• Task management skills with ability to prioritize multiple assignments.


• Strong problem solving and analytical skills.

• 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.

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, andwellness 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.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.