Mechanical Engineer, Medical Devices (Onsite, Cross-Functional)

KeyPoint Staffing; Foxborough (MA); On-site; USD 100,000 - 150,000; Full time

Job summary

KeyPoint Staffing is seeking a senior Mechanical Engineer for a growing medical device company in Massachusetts. The role is onsite and encompasses design, development, testing, and optimization of innovative medical devices across the full product lifecycle.

The ideal candidate has 5+ years of product design experience, proficiency in SolidWorks, and knowledge of manufacturing processes and quality systems.

Qualifications

• Bachelor's degree in Mechanical Engineering or related field; 5+ years design and development experience.
• Proficiency in SolidWorks CAD software and design for manufacturability.
• Experience with FDA QSR and ISO 13485 Design Controls.
• Strong project management, organizational and problem-solving capabilities.
• Excellent written and verbal communication skills; able to manage multiple priorities.

Responsibilities

• Design and develop mechanical components, subsystems, and assemblies.
• Create and maintain 3D models, drawings, and product specifications using SolidWorks.
• Plan, execute, and document characterization, verification, and environmental testing activities.
• Develop test protocols and generate test reports for product validation.
• Collaborate with suppliers to source, evaluate, and qualify components and processes.
• Ensure manufacturability and automation considerations; partner with operations and quality teams.
• Translate customer requirements into engineering solutions and deliverables milestones.
• Maintain development documentation to meet regulatory and quality requirements.
• Identify and mitigate risks related to product performance, reliability, and cost.

Skills

Product design

Project management

Quality systems

Problem solving

Communication

Independent work

Cross-functional collaboration

Education

Bachelor's degree in Mechanical Engineering

Master's degree (preferred)

Tools

SolidWorks

Microsoft Project

MS Office

Job description

KeyPoint Staffing is seeking a senior Mechanical Engineer for a growing medical device company in Massachusetts. The role is onsite and encompasses design, development, testing, and optimization of innovative medical devices across the full product lifecycle.

The ideal candidate has 5+ years of product design experience, proficiency in SolidWorks, and knowledge of manufacturing processes and quality systems.