Mechanical Engineer

Our client is seeking a Mechanical Engineer II to support the design, development, testing, and optimization of innovative medical devices. This role will collaborate cross-functionally with engineering, quality, operations, supply chain, and management teams throughout the product development lifecycle—from concept and prototype development through testing, validation, and manufacturing readiness.The ideal candidate will bring strong mechanical design experience, a hands-on engineering approach, and a passion for developing products in a regulated medical device environment.

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 to support 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 requirements and manufacturability standards.
• Translate customer and project requirements into engineering solutions and project 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.
• Assess and mitigate risks related to product performance, reliability, safety, cost, and scalability.
• Support continuous improvement initiatives related to product design, manufacturing processes, and engineering best practices.

Qualifications

Required

• Bachelor's degree in Mechanical Engineering or related engineering discipline.
• 5+ years of product design and development experience.
• Proficiency with SolidWorks CAD software.
• Experience leading or contributing to new product development initiatives.
• Knowledge of manufacturing processes including injection molding, metal forming, welding, and mechanical assembly techniques.
• Experience designing products for manufacturing and automation.
• Working knowledge of FDA Quality System Regulations (QSR) and ISO 13485 Design Controls.
• Strong project management, organizational, and problem-solving skills.
• 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.

Preferred

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

Work Environment

• Professional office, laboratory, and cleanroom environment.
• Collaborative, team-oriented culture with opportunities for cross-functional engagement.
• Business casual dress code.
• Standard business hours: Monday through Friday, 8:00 AM – 5:00 PM.

Physical Requirements

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

Additional Information

• This position requires full-time onsite attendance.
• Occasional travel to customer sites may be required.
• No direct supervisory responsibilities; however, the role may provide guidance or oversight on specific projects and tasks as needed.