Senior Mechanical Engineer - Medical Devices (Onsite)

Keypoint Staffing; Boston (MA); Vor Ort; USD 110.000 - 160.000; Vollzeit

Zusammenfassung

Keypoint Staffing seeks a Mechanical Engineer for a growing medical device organization on a full-time, on-site basis in the Boston area. You will design assemblies, create SolidWorks models, and support verification across the product development lifecycle from concept through manufacturing readiness.

The role requires a Bachelor’s in Mechanical Engineering, 5+ years of design experience, and familiarity with FDA QSR/ISO 13485.

Qualifikationen

• Bachelor's degree in Mechanical Engineering or related discipline required.
• 5+ years of product design and development experience.
• Proficiency in SolidWorks CAD software.
• Experience leading or contributing to new product development programs.
• Knowledge of manufacturing processes incl. injection molding, metal forming, welding, and mechanical assembly.
• Experience designing for manufacturability and automation.
• Working knowledge of FDA QSR and ISO 13485 Design Controls.
• Strong project management, organizational, and problem-solving capabilities.
• Proficiency with Microsoft Office and Microsoft Project.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple priorities in a fast-paced environment.

Aufgaben

• Design and develop mechanical components, subsystems, and complete medical device assemblies.
• Create and maintain 3D models, drawings, and specs in SolidWorks.
• Plan, execute, and document characterization, verification, and environmental testing.
• Develop test protocols and generate test reports for validation.
• Collaborate with suppliers to source, evaluate, and qualify components and processes.
• Partner with operations and quality to ensure manufacturability and compliance.
• Translate requirements into engineering deliverables and milestones.
• Participate in cross-functional design reviews and technical discussions.
• Prepare and maintain development documentation per regulatory and quality requirements.
• Identify and mitigate risks related to performance, reliability, safety, cost, and scalability.
• Support continuous improvement of design and manufacturing processes.

Kenntnisse

Project management

Communication

Problem-solving

Independent work

Cross-functional collaboration

Design optimization

Ausbildung

Bachelor's in Mechanical Engineering

Master's in Engineering (preferred)

Tools

SolidWorks

Microsoft Office

Microsoft Project

Jobbeschreibung

Keypoint Staffing seeks a Mechanical Engineer for a growing medical device organization on a full-time, on-site basis in the Boston area. You will design assemblies, create SolidWorks models, and support verification across the product development lifecycle from concept through manufacturing readiness.

The role requires a Bachelor’s in Mechanical Engineering, 5+ years of design experience, and familiarity with FDA QSR/ISO 13485.