Project Engineer Biologics

Lower Providence Township, PA, United States

About Us :

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 Project Engineer in the regenerative biologics division will be responsible for all engineering functions of their product lines, which may include recombinant proteins and other biologic products. This includes bringing a product from idea/concept through design, prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction, and post introduction monitoring.

Essential Functions :

Develops processes for ruse in orthopedic applications and other therapeutic applications, including recombinant proteins

Develops protocols for in vitro and in vivo evaluation of biocompatibility and efficacy

Performs design verification and validation activities to ensure designs meet specifications

Works with Regulatory and quality departments to provide technical support for INTERACT/Q-sub drafts

Manages all aspects of the project to ensure timely completion of tasks while remaining in full compliance with the Globus quality system and other applicable regulatory bodies.

Works with the operations department to set up manufacturing and/or purchasing as appropriate for each project

Assists with product introductions through sales training, customer calls/visits, etc.

Maintains diligent post introduction monitoring to address customer requests for changes

Researches market and competition on an ongoing basis to ensure that Globus has cutting edge technology in all markets entered

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 uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications :

Familiarity with CBER and CDRH requirements for biologic and combination devices

2+ years of engineering/development experience with a focus on protein structure and function

MS in a scientific field including biochemistry, structural biology, molecular immunology, or related discipline; Ph.D. is highly desirable

Experience designing and performing analytical assays

Experience with lyophilization development and/or familiarity with the biopharmaceutical industry is preferred.

Hands-on experience and prototyping and testing of biomaterial formulations.

Ability to manage multiple projects simultaneously and effectively within a fast-paced environment

Ability to travel 10-15%

Will be required to attend surgeries and/or labs

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.

Physical Demands :

The physical demands listed here are representative of those that must be met by and 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 10 pounds, and occasionally lift and/or move up to 25 pounds

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

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.

#J-18808-Ljbffr