Mechanical Engineer

Position Overview

SchureMed, a global manufacturer of surgical patient positioning devices, is seeking a detail-oriented and innovative Mechanical Engineer to join our Research and Development team. This role is critical to both the development of new medical devices and the support of our existing product portfolio. The ideal candidate will bring hands-on engineering expertise, proficiency in SolidWorks, and a strong understanding of regulated manufacturing environments.

Key Responsibilities

Create and maintain technical drawings and 3D models using SolidWorks

Manage Product Data Management (PDM) systems and organize engineering files

Design and document prototypes, fixtures, and tooling using CAD tools

Write and execute test protocols, including V&V, IQ / OQ / PQ, and Gage R&R studies

Process and manage Engineering Change Orders (ECOs)

Conduct inspections and document results for prototype components

Assemble, troubleshoot, and refine product designs and systems

Analyze test data to recommend design or process improvements

Research, source, and implement tooling and equipment

Prepare engineering documentation for production, including test methods and work instructions

Collaborate with manufacturing on pilot production and process improvements

Train team members on new procedures and tools

Ensure compliance with ISO 13485, QSR 21 CFR 820, GMP, and other applicable regulations

Support additional engineering initiatives as needed

Qualifications

Bachelor's degree in Mechanical Engineering or related field

3-5 years of experience in product development or manufacturing

Proficiency in SolidWorks and CAD software

Strong skills in documentation, data entry, and analysis

Experience working in a regulated environment (ISO 13485, QSR, GMP)

Skills & Competencies

Proficiency in Microsoft Word, Excel, and PowerPoint

Excellent communication, organizational, and time management skills

Detail-oriented with strong problem-solving abilities

Ability to work independently and collaboratively across departments

Able to manage multiple priorities in a fast-paced setting

Why Join SchureMed?

SchureMed is a global manufacturer with over 30 years of experience designing and producing innovative surgical positioning solutions. All of our products are proudly made in the USA and distributed worldwide. Join a dedicated team making a difference in operating rooms every day-with opportunities to grow, innovate, and leave a lasting impact.