Mechanical Engineer - Medical Device Hardware & Testing

Custom Health Inc; Morrisville (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Spencer Health Solutions in Morrisville, NC is seeking a Mechanical Engineer to join the hardware team. The role focuses on drafting, modeling, and developing Spencer’s medical device hardware while ensuring compliance with quality management systems.

Responsibilities include defining new products with engineers, performing hardware qualification testing, and contributing to process improvements and vendor qualification to meet customer requirements.

Qualifications

• Bachelor-level degree in mechanical engineering or equivalent.
• 4–10 years’ experience designing and developing commercial or consumer products.
• Experience with drafting and modeling in CAD; SolidWorks preferred.
• Experience with prototyping and plastics (injection molding).
• Strong knowledge of hardware qualification testing of POC’s.
• Experience working in a regulated environment; adherence to SOPs.

Responsibilities

• Drafting and modeling of hardware components.
• Collaborate with engineers to define new products and ensure they meet customer requirements.
• Perform hardware qualification testing of POC’s.
• Analyze designs, run tests, and study feasibility for improvements in design, cost, or time-to-market.
• Qualify vendors per Spencer’s specifications and participate in process improvements.
• Create manufacturing instructions and specifications and ensure compliance with Spencer’s Quality Management System.

Skills

Problem solving

Interpersonal skills

Regulated environment experience

SOP adherence

Education

Degree in mechanical engineering

Tools

SolidWorks

Parametric CAD

Injection Molding

Job description

Spencer Health Solutions in Morrisville, NC is seeking a Mechanical Engineer to join the hardware team. The role focuses on drafting, modeling, and developing Spencer’s medical device hardware while ensuring compliance with quality management systems.

Responsibilities include defining new products with engineers, performing hardware qualification testing, and contributing to process improvements and vendor qualification to meet customer requirements.