Mechanical Engineer II - Contractor

Mechanical Engineer II

This role is a Mechanical Engineer II position focused on the development of medical devices and electromechanical/electro-pneumatic products. The engineer is responsible for translating customer requirements into designs, creating and testing prototypes, supporting manufacturing processes, performing design verification, and contributing to product development projects from concept through validation.

Key Responsibilities

• Interpret customer specifications and convert them into mechanical design requirements.
• Create 3D CAD models, detailed drawings, and tolerance analyses using SolidWorks or similar CAD tools.
• Perform engineering analysis to support design decisions.
• Develop and evaluate prototypes, tooling, equipment, and manufacturing processes.
• Conduct troubleshooting and resolve design, fabrication, and processing issues.
• Develop test methods, fixtures, verification protocols, and technical reports.
• Analyze test data and provide recommendations for product improvements.
• Collaborate with internal teams and external suppliers on fabrication, inspection, and testing activities.
• Contribute to project planning, execute assignments independently, and support schedule management.
• Train technicians and operators on new processes and production techniques.

Required Skills & Expertise

• Knowledge of Design for Manufacturability and Assembly (DFM&A).
• Experience with SolidWorks and 3D CAD modeling.
• Understanding of manufacturing processes including: injection molding, plastic extrusion, castings, sheet metal fabrication, metal stampings, machining, additive manufacturing.
• Familiarity with ANSI/ISO drafting standards, GD&T, tolerance analysis, and mechanical testing methods.
• Strong analytical, problem-solving, mathematical, and communication skills.
• Experience with electronic document control systems and design documentation.
• Ability to work effectively in cross-functional teams and manage multiple priorities.

Technical & Regulatory Knowledge

• Experience operating laboratory and test equipment, including pressure/flow measurement devices, environmental chambers, oscilloscopes, DVMs, simulators, and data acquisition systems.
• Ability to use basic shop tools and equipment for prototype development.
• Understanding of simple wiring diagrams.
• Familiarity with Agile Scrum and Waterfall project management methodologies.
• Knowledge of medical device regulations and quality systems, including ISO 13485, ISO 7198, Good Manufacturing Practices (GMP).

Minimum Qualifications

• Bachelor's degree in Engineering (Mechanical Engineering preferred).
• 2 to 4 years of relevant engineering experience, or a Master's degree with less than one year of experience.
• Experience with SolidWorks or another solid-modeling CAD platform.
• Background in medical device/equipment development, particularly electromechanical, electro-pneumatic, or blood-pumping systems.
• Proficiency with Microsoft Office, Windows, and Adobe Acrobat.
• Preferred experience with Microsoft Visio and Microsoft Project.

Ideal Candidate Profile

An early-to-mid career mechanical engineer with experience in medical device product development, 3D CAD design, prototype development, and manufacturing support, who can independently execute engineering assignments while collaborating with multidisciplinary teams to bring regulated medical products from concept to production.