Mechanical Engineer

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

Description

ABOUT spencer®

Spencer Health Solutions (www.spencerhealthsolutions.com) is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists and family members digitally.

The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada and Europe.

About Custom Health (Parent Owner)

Custom Health provides a comprehensive tech-enabled med management and managed care solution resulting in 98% medication adherence for our patients across the United States and Canada. Operations are powered by proprietary software which orchestrates fully automated owned and network pharmacies, at-home medication management solutions, real-time clinical oversight by 200+ pharmacist-lead clinicians and the collection of real-time, real-world data and insights.

Mechanical Engineer

Morrisville, North Carolina

SUMMARY

The Mechanical Engineer works alongside other hardware engineers on all activities relating to Spencer mechanical engineering efforts. The Mechanical Engineer will assist in design, development, and related activities across various projects. Ensure excellence and compliance in project execution by following effective project management and inter-departmental collaboration. Help in change management, project planning, and actively participate in continuous process improvement.

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.

Spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class.

Requirements

REQUIREMENTS

• 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

PREFERRED

• Medical Device Background: Direct experience working under FDA/EMA regulatory frameworks and medical-grade quality management systems.
• ISO Standards: Familiarity with ISO 14971 (Risk Management), IEC 62366 (Medical Device), and IEC 60601 (Safety/Essential Performance).