Associate MedTech Project Engineer – OR & R&D

NML Medical; Lower Providence Township (PA); Presencial; USD 65.000 - 95.000; Jornada completa

Descripción de la vacante

Globus Medical in the United States is seeking a junior Mechanical/Biomedical Engineer to join the product development team. You will design and extend medical device lines, work with R&D, regulatory, and clinical teams, and help validate device performance in cadaver labs and OR settings.

With 0–2 years of experience, you will apply CAD tools (CREO or SolidWorks), analyze data in Excel, and contribute to SFJ/DOC processes while learning ISO 13485 and FDA 21 CFR Part 820 requirements.

Formación

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field.
• 0–2 years of product development or sustaining engineering experience in the medical device industry.
• Proficiency with CAD software (CREO or SolidWorks) for mechanical design and documentation.
• Proficiency with Microsoft Excel, PowerPoint, and Project for data analysis, presentations, and project tracking.
• Strong analytical and problem-solving skills with attention to detail.
• Effective verbal and written communication skills for cross-functional collaboration.
• Ability to thrive in both engineering and clinical environments, including operating rooms and cadaver labs.
• Familiarity with risk management principles and design control processes in regulated industries.

Responsabilidades

• Design and implement product line extensions, working closely with the R&D, clinical, and regulatory teams.
• Champion Design for Manufacturing (DFM) improvements across launched product lines to optimize cost, reliability, and manufacturability.
• Resolve manufacturing challenges through vendor coordination and iterative design updates.
• Provide technical support during cadaver labs and customer engagement meetings to validate and refine device performance.
• Support surgical cases in the operating room, working directly with surgeons to gather real-time feedback and identify clinical opportunities for improvement.
• Perform product scrap analysis and coordinate remediation strategies to improve yield and performance.
• Conduct complaint evaluations, identify root causes, and implement corrective actions in collaboration with cross-functional teams.
• Lead and contribute to Post-Market Surveillance Reports (PMSR) and Periodic Safety Update Reports (PSUR) in compliance with global regulatory standards.
• Drive risk analyses to assess and mitigate design and process risks.

Conocimientos

Analytical skills

Effective communication

Teamwork

Educación

Bachelor’s degree in Mechanical Engineering

Biomedical Engineering or related field

Herramientas

CREO

SolidWorks

Descripción del empleo

Globus Medical in the United States is seeking a junior Mechanical/Biomedical Engineer to join the product development team. You will design and extend medical device lines, work with R&D, regulatory, and clinical teams, and help validate device performance in cadaver labs and OR settings.

With 0–2 years of experience, you will apply CAD tools (CREO or SolidWorks), analyze data in Excel, and contribute to SFJ/DOC processes while learning ISO 13485 and FDA 21 CFR Part 820 requirements.