Associate Project Engineer, Sustaining

Globus Medical, Inc.; 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

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

Key Responsibilities

• 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.
• Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
• Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role Representing the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Required Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or a related field.
• 0-2 years of experience in product development or sustaining engineering within the medical device industry.
• Proficiency with CAD software (CREO or SolidWorks preferred) 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.

Preferred Qualifications

• Internship or co-op experience in a regulated industry, ideally medical devices.
• Exposure to post-market surveillance activities or complaint handling systems.
• Understanding of ISO 13485, FDA 21 CFR Part 820, or EU MDR regulations.

Our Values

Our Life Moves Us philosophy is built on four values: Passionate About Innovation, Customer Focused, Teamwork, and Driven.

• Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate in our role in improving the lives of patients by continuously developing better solutions.
• Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
• Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
• Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Equal Employment Opportunity

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship. We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.