Mechanical Designer

Job Title:

Mechanical Designer

Job Description

This role focuses on designing innovative medical devices by integrating electrical and mechanical systems, with a strong emphasis on injection molded components and capital equipment. The Mechanical Designer uses Solid Works and related tools to ideate, model, and document complex assemblies, supporting the development of a state-of-the-art minimally invasive prostate cancer therapy device that has received U.S. FDA Breakthrough Device Designation.

Responsibilities

* Create and refine mechanical and electrical designs for medical devices using Solid Works, including complex assemblies and detailed components.

* Ideate and sketch multiple design concepts, then translate these concepts into 3D component and assembly models and detailed engineering drawings.

* Design injection molded parts, including at least 10 unique components, with a strong preference for extensive experience across 50 or more parts.

* Develop fixturing designs for test methods, laboratory equipment, and production or manufacturing applications to support verification and validation activities.

* Integrate electrical and mechanical components within capital systems such as infusion pumps, CT, MRI, X-ray, ventilators, dialysis equipment, and surgical devices.

* Use Product Data Management (PDM) systems to manage CAD files, configurations, and document change orders in a controlled environment.

* Collaborate closely with engineers and technicians to communicate design concepts, ideas, and sketches clearly and effectively.

* Support prototyping activities, including preparing models for 3D printing and evaluating prototypes to validate form, fit, and function.

* Apply drafting standards and CAD best practices to ensure accuracy, manufacturability, and compliance with medical device design requirements.

* Contribute to continuous improvement of design processes, documentation practices, and design standards within the mechanical team.

Essential Skills

* CAD/drafting degree from a two-year technical college or equivalent technical education.

* 3+ years of mechanical design experience, including 2 to 5 years of hands-on Solid Works use.

* Proven product design experience with capital electrical and mechanical systems such as infusion pumps, CT, MRI, X-ray, ventilators, dialysis, or surgical equipment.

* Medical device design experience, particularly in regulated environments.

* Demonstrated experience designing injection molded parts, including at least 10 parts and preferably over 50 parts for injection molding.

* Extensive experience designing fixtures for test methods, lab equipment, and production or manufacturing applications.

* Strong electrical and mechanical aptitude, with experience integrating electrical and mechanical components into cohesive systems.

* Proficiency in Solid Works for component modeling, assembly modeling, and detailed drawing creation.

* Experience using Product Data Management (PDM) systems to manage CAD data and document change orders.

* Ability to clearly communicate concepts, ideas, and sketches to engineers and technicians, both verbally and through visual documentation.

Additional

Skills & Qualifications

* Experience with Grand Avenue Software in conjunction with Solid Works.

* Familiarity with master reference geometry that links to multiple child parts in parametric CAD environments.

* Experience with drafting standards, CAD documentation, and document change order processes.

* Background in electrical design and mechanical design within multidisciplinary product development teams.

* Ability to support prototyping efforts, including preparation of models for 3D printing and iterative design refinement.

* Strong collaboration skills and comfort working in a highly interactive, cross-functional engineering environment.

* Motivation to contribute to innovative medical technologies, including minimally invasive prostate cancer therapy devices recognized with U.S. FDA Breakthrough Device Designation.

Work Environment

This position is 100% on-site in a highly collaborative mechanical engineering environment. The Mechanical Designer works closely with four other members of the…