Purpose and Scope
The Principal Mechanical Design Engineer will lead mechanical design activities focused on the development of Monteris Medical’s capital equipment and disposable products. This role requires strong experience in medical device product development with a focus on design for manufacturability (DfM), system-level integration, and life-cycle support of complex electromechanical systems.
The ideal candidate will demonstrate expertise in mechanical design of capital equipment systems and bring valuable insights from working with single-use disposable medical devices. This is a critical role that interfaces with cross-functional teams to drive innovation, improve product reliability, and ensure robust design execution in compliance with regulatory standards.
Primary Organization Responsibilities
- Lead and execute mechanical design activities for capital equipment and disposables from concept through commercialization.
- Drive DfM principles into design solutions and support smooth transition to manufacturing.
- Partner with electrical, software, systems, and manufacturing teams to ensure robust system-level integration.
- Identify and assess mechanical design options and trade-offs to meet functional, cost, and reliability targets.
- Lead supplier and material selection efforts to ensure ease of manufacturing.
- Generate detailed 3D CAD models, drawings, and documentation in accordance with quality system requirements.
- Participate in and lead design reviews, risk analyses, and design verification/validation activities.
- Support sustaining engineering activities including product improvements, cost reductions, and part obsolescence.
- Assist complaint investigations, CAPAs, NCRs, and other product related issues.
- Mentor junior engineers and provide technical leadership across cross-functional teams.
- Ensure compliance with FDA and ISO standards in all aspects of product development and documentation.
Personal Qualifications and Experience
Education/Experience
- Bachelor’s degree or higher in Mechanical Engineering or related discipline.
- Minimum of 8+ years of experience in mechanical design and product development within the medical device industry.
- Experience designing capital equipment systems and Class II/III disposable components.
- Extensive background in best practices for DfM, mechanical tolerance analysis, and root cause problem solving.
Skills/Abilities
- Proficiency with CAD tools such as SolidWorks or equivalent.
- Knowledge of a range of manufacturing processes: machining, injection molding, sheet metal, and additive manufacturing.
- Strong understanding of mechanical systems integration with electrical and software components.
- Experience with design verification, validation, and reliability testing.
- Working knowledge of ISO 13485, FDA QSR, and design controls.
- Excellent documentation, organizational, and communication skills.
- Ability to lead complex projects and mentor junior staff.
- Demonstrated collaboration in cross-functional product development environments.