Mechanical Engineer – MedTech Hardware for Home Care

Custom Health Inc.; Morrisville (NC); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Spencer Health Solutions in Morrisville, NC seeks a Mechanical Engineer to join hardware teams on multiple projects. You will assist in design, development, and related activities, ensuring quality and compliance while collaborating across departments.

The role involves change management, project planning, and continuous process improvement within a medical device framework. Experience in regulated environments is preferred.

Qualifications

• Degree in mechanical engineering.
• 4 to 10 years’ experience design and development of commercial or consumer products.
• Experience in drafting and modeling in parametric CAD software tools, SolidWorks preferred.
• Experience in Prototyping & Mockups with Plastics (Injection Molding).
• Strong knowledge of hardware qualification testing of POC’s.
• Strong interpersonal skills and innovative problem-solving skills.
• Experience working in a regulated environment
• Ability to read, understand, and execute job functions in accordance with Standard Operating Procedures

Responsibilities

• Drafting and modeling of hardware components.
• Work closely with other engineers to define new products and ensure products meet or exceed customer requirements.
• Performs hardware qualification testing of POC’s
• Analyze designs, perform testing, and do feasibility studies of subsystems, assemblies, and their components to identify opportunities for design, cost, or time-to-market improvements.
• Qualifies vendors as per Spencer’s specifications.
• Participates in process improvement activities.
• Creates manufacturing instructions and specifications.
• Ensures all hardware design activities are accomplished within Spencer’s Quality Management System.

Skills

Mechanical design

SolidWorks

Prototyping

Hardware testing

Regulated environment

Team collaboration

Education

Bachelor's degree in Mechanical Engineering

Tools

SolidWorks CAD

Parametric CAD tools

Job description

Spencer Health Solutions in Morrisville, NC seeks a Mechanical Engineer to join hardware teams on multiple projects. You will assist in design, development, and related activities, ensuring quality and compliance while collaborating across departments.

The role involves change management, project planning, and continuous process improvement within a medical device framework. Experience in regulated environments is preferred.