Mechanical Engineer – Medical Devices

Position Overview

We are seeking an experienced Mechanical Engineer to support the design, development, testing, and optimization of innovative medical devices. This role will work closely with Engineering, Quality, Operations, Supply Chain, and other cross-functional teams throughout the product development lifecycle.

The Mechanical Engineer will be involved in mechanical design, materials and component selection, prototype development, testing, validation, and technical documentation. The ideal candidate has strong hands-on design experience, excellent problem-solving skills, and a solid understanding of medical device development and regulatory requirements.

Key Responsibilities

Mechanical Design & Product Development

• Design and develop mechanical components, assemblies, and medical devices.
• Create detailed 3D models, engineering drawings, specifications, and design documentation.
• Evaluate design concepts for functionality, reliability, manufacturability, safety, and cost.
• Develop and refine components, subsystems, and complete assemblies.
• Translate customer and product requirements into practical engineering designs and project milestones.
• Support new product development from concept through production.
• Identify and resolve mechanical design challenges throughout the development process.

Testing & Validation

• Develop and execute product characterization and environmental testing.
• Create test plans, protocols, procedures, and acceptance criteria.
• Participate in prototype testing and product evaluations.
• Analyze test results and prepare comprehensive technical reports.
• Identify design risks and develop solutions to improve product performance and reliability.
• Support design verification and validation activities.
• Ensure testing is completed accurately and within established project timelines.

Manufacturing & Supplier Collaboration

• Work with suppliers to identify and qualify materials, components, tooling, and manufacturing processes.
• Support supplier selection and technical evaluations.
• Collaborate with Operations and Manufacturing teams to ensure designs are practical and scalable for production.
• Apply design-for-manufacturability principles throughout product development.
• Work with manufacturing partners on processes such as injection molding, metal forming, welding, and plastic/metal joining.
• Support development of automated and semi-automated manufacturing processes.
• Evaluate opportunities to improve manufacturing efficiency, product quality, and cost.

Quality & Regulatory Compliance

• Work closely with Quality Assurance to ensure products meet design specifications and applicable requirements.
• Prepare and review technical documentation supporting product feasibility, development, testing, and manufacturing.
• Support compliance with applicable FDA Quality System Regulation (QSR) and ISO 13485 requirements.
• Apply design control principles throughout the product development process.
• Participate in design reviews, risk assessments, and corrective actions.
• Identify and mitigate risks related to product safety, reliability, functionality, cost, and manufacturability.

Cross-Functional Collaboration

• Collaborate with Engineering, Quality, Operations, Supply Chain, and management throughout product development.
• Participate in cross-functional project meetings and provide technical recommendations.
• Communicate project status, technical challenges, and potential solutions to stakeholders.
• Coordinate engineering activities to meet project milestones and deadlines.
• Help ensure engineering projects align with organizational objectives and product requirements.
• Provide technical support to other departments as needed.

Required Qualifications

• Bachelor's degree in Mechanical Engineering or a related engineering discipline.
• 5+ years of mechanical design engineering experience.
• Strong proficiency with SolidWorks or similar 3D CAD software.
• Experience developing new products, technologies, and manufacturing processes.
• Experience with injection molding, metal forming, welding, and other joining methods.
• Experience with design for manufacturing and/or design for automation.
• Understanding of mechanical design principles, materials, tolerances, and manufacturing processes.
• Working knowledge of FDA QSR and ISO 13485 Design Controls.
• Strong analytical, problem-solving, and project management skills.
• Excellent written and verbal communication skills.
• Proficiency with Microsoft Office and project management tools such as Microsoft Project.
• Ability to work independently with minimal supervision.
• Ability to manage multiple priorities and consistently meet project deadlines.

Preferred Qualifications

• Master's degree in Engineering or a related technical discipline.
• 7+ years of medical device engineering experience.
• Experience working in an FDA-regulated and ISO 13485-compliant design and manufacturing environment.
• SolidWorks certification or advanced SolidWorks expertise.
• Experience with electro-mechanical instrumentation.
• Experience with robotics, automation, or automated manufacturing systems.
• Experience with medical device testing, validation, and design verification.
• Experience with risk management and product development documentation