Globus Medical
Medical Device
AssociateProjectEngineer
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Associate Project Engineer at Globus Medical. Skills: Medical device development, Biologics development, Regulatory compliance, Process development. Offer technical support for medical device and biologic products. Conduct research and development”
What You'll Achieve.
Improve the quality of life of patients; Improve the techniques and outcomes of surgery; Uphold product quality standards
Industry & Context.
Exceptional problem-solving skills
Required to climb or stoop, kneel, crouch or crawl, Required to regularly lift and/or move up to 25 pounds, Occasionally lift and/or move up to 65 pounds, Possess specific vision abilities, Adhere to company Code of Conduct, Adhere to AdvaMed Code, Adhere to MedTech Code, Ensure compliance with governmental laws, rules, and regulations
What They're Looking For.
Must Have
Bachelor's or Master's degree in Biomedical Engineering, Biomedical Sciences, or a related field, Wet lab experience, Hands-on experience in process development, manufacturing, or quality systems for medical devices, biologics or combination products, Solid understanding of stability studies, analytical characterization, and process validation, In-depth understanding of CMC (Chemistry, Manufacturing, and Controls) regulatory considerations, Organizational skills with demonstrated experience in documentation, data tracking, and regulatory compliance
Nice to Have
Industry experience strongly preferred, Industry experience supporting medical devices as well as early-stage biologics or combination product development
What You'll Do.
Offer technical support for medical device and biologic products
Conduct research and development
Perform sustaining engineering activities
and validate medical devices/biologic products
Serve as subject matter expert on commercialized offerings
Design and execute experimental protocols
Collect and analyze data
Provide comprehensive reports on findings
Maintain meticulous experimental records
Draft detailed technical reports
Ensure compliance with quality and regulatory standards
Coordinate and oversee pre-clinical and biocompatibility studies
Author and review technical documents
Stay updated on emerging trends and advancements
Contribute to innovation
How You'll Work.
Team & Collaboration
Partnering with researchers and educators; Working together; Supporting each other
Communication Scope
Exceptional communication skills
Process & Methodology
Managing project timelines, Managing deliverables
Full Job Description
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 biocomp
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