Associate Project Engineer

Globus Medical, Inc.

Audubon, PA

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JOB DETAILS

SKILLS

Biology, Biomedical Engineering, Business Practices, Capacity Allocations, Chemistry, Corporate Policies, Customer Relations, Data Analysis, Data Collection, Depth Perception, Documentation, Experiment Design, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), Government Regulations, Healthcare Providers, Healthcare Quality, Investigational New Drug (IND), Laboratory, Lift/Move 25 Pounds, Maintain Compliance, Manufacturing, Medical Equipment, Organizational Skills, Patient Care, Philosophy, Physical Demands, Pre-Clinical Trials, Problem Solving Skills, Process Development, Process Manufacturing, Process Validation, Product Development, Product/Service Launch, Project Engineering, Project/Program Management, Quality Metrics, Quality of Life, Record Keeping, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Research & Development (R&D), Research Skills, Scientific Publications, Stability Analysis, Standard Operating Procedures (SOP), Standards Development, Surgical Procedures, Team Player, Technical Delivery, Technical Drawing, Technical Support, Technical Writing, Time Management, Trend Analysis

LOCATION

Audubon, PA

POSTED

3 days ago

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.

Position Summary:

The Associate Project Engineer will offer technical support for the advancement of medical device and biologic products. This role entails conducting research and development, as well as sustaining engineering activities on launched products. Responsibilities include developing, optimizing, and validating medical devices/biologic products to uphold product quality standards as well as serving as a subject matter expert on commercialized offerings. Candidates must hold a Bachelor’s or Master’s degree in Biomedical Engineering, Biomedical Sciences, or a related field, with prior wet lab experience and industry experience strongly preferred.

Essential Functions:

+ Conducts development and maintenance activities for early stage and sustaining projects in the Regenerative Biologics Division portfolio, respectively

+ Designs and executes experimental protocols, collects and analyzes data, and provides comprehensive reports on findings

+ Maintains meticulous experimental records, drafts detailed technical reports, and ensures strict compliance with applicable quality and regulatory standards

+ Possesses in-depth knowledge of CBER (Center for Biologics Evaluation and Research) and CDRH (Center for Devices and Radiological Health) regulatory requirements for biologics and combination devices, ensuring full compliance with GMP standards in product development and manufacturing

+ Coordinates and oversees pre-clinical and biocompatibility studies, ensuring timely execution and regulatory alignment

+ Authors and reviews a variety of technical documents, including SOPs, protocols, regulatory submissions (IND, BLA), and scientific publications, ensuring clarity and accuracy

+ Stays updated on emerging trends and advancements in relevant technologies and actively contributes to innovation within the Regenerative Biologics Division

+ Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies

+ Ensures 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

+ Represents the company in a professional manner and upholds 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._

Qualifications:

+ B.S. or M.S. in Biology, Biomedical Engineering, Biomedical Sciences, or a related field required

+ Exceptional communication and problem-solving skills required

+ Capable of independently managing project timelines and deliverables

+ Industry experience supporting medical devices as well as early-stage biologics or combination product development strongly preferred

+ Comprehensive knowledge of GMP, FDA, CBER, and CDRH regulatory requirements

+ Hands-on experience in process development, manufacturing, or quality systems for medical devices, biologics or combination products required

+ Solid understanding of stability studies, analytical characterization, and process validation

+ In-depth understanding of CMC (Chemistry, Manufacturing, and Controls) regulatory considerations

+ Strong organizational skills with demonstrated experience in documentation, data tracking, and regulatory compliance

Physical Demands:

The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

+ Required to sit; climb or balance; and stoop, kneel, crouch or crawl

+ Required to regularly lift and/or move up to 25 pounds and occasionally lift and/or move up to 65 pounds

+ Required to possess specific visons abilities, including close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus

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.

About the Company

Globus Medical, Inc.

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