Mechanical Engineer

Position Overview

A growing medical device organization is seeking a Mechanical Engineer II to support the design, development, testing, and optimization of innovative medical device products. This role is fully onsite and collaborative in nature, working cross-functionally with engineering, quality, operations, supply chain, and leadership teams across the full product development lifecycle — from early concept and prototyping through validation and manufacturing readiness.

Key Responsibilities

• Design and develop mechanical components, subsystems, and complete medical device assemblies
• Create and maintain detailed 3D models, engineering drawings, and product specifications using SolidWorks
• Plan, execute, and document characterization, verification, and environmental testing activities
• Develop test protocols and generate comprehensive test reports in support of product validation
• Collaborate with suppliers to source, evaluate, and qualify components, tooling, and manufacturing processes
• Partner with operations and quality teams to ensure products meet design and manufacturability requirements
• Translate customer and project requirements into engineering solutions and deliverable milestones
• Participate in cross-functional design reviews and technical discussions to identify and resolve design challenges
• Prepare and maintain product development documentation in compliance with customer, regulatory, and quality requirements
• Identify and mitigate risks related to product performance, reliability, safety, cost, and scalability
• Support continuous improvement efforts related to product design, manufacturing processes, and engineering best practices

Qualifications

Required:

• Bachelor's degree in Mechanical Engineering or a related engineering discipline
• 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 including injection molding, metal forming, welding, and mechanical assembly
• Experience designing products for manufacturability and automation
• Working knowledge of FDA Quality System Regulations (QSR) and ISO 13485 Design Controls
• Strong project management, organizational, and problem-solving capabilities
• Proficiency in Microsoft Office and Microsoft Project
• Excellent written and verbal communication skills
• Ability to work independently and manage multiple priorities in a fast-paced environment

Preferred:

• Master's degree in Engineering or a related field
• 7+ years of medical device engineering experience
• Experience working within FDA-regulated and ISO 13485-certified manufacturing environments
• SolidWorks Expert Design Certification
• Background in electro-mechanical systems, instrumentation, robotics, or automation technologies

Work Environment & Schedule

• Professional office, laboratory, and cleanroom setting
• Collaborative, team-oriented culture with broad cross-functional exposure
• Business casual dress code
• Standard hours: Monday – Friday, 8:00 AM – 5:00 PM
• Full-time onsite attendance required
• Occasional travel to customer sites may be needed
• No direct supervisory responsibilities; project-level guidance may be provided as needed

Physical Requirements

• Ability to work at a computer for extended periods
• Full wrist, hand, and finger dexterity required for engineering and laboratory tasks
• Comfortable working in engineering lab and cleanroom environments

Equal Opportunity Statement

This employer is committed to building a diverse and inclusive workplace. All qualified applicants will be considered without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, or local law.