Bone Bank Allografts
Medical Devices
SustainingEngineer
Neural analysis suggests this role is
optimal for Entry candidates.
“Sustaining Engineer at Bone Bank Allografts. Skills: Design engineering, Biomaterials, Product lifecycle management. Engineering functions of existing product lines. Continuous improvement ideation”
What You'll Achieve.
Ensure high quality of all products continue throughout their lifecycles; Support product development; Support lifecycle management; Drive process optimization; Ensure full compliance with internal quality systems; Ensure compliance with applicable regulatory standards
Industry & Context.
Root Cause Analysis (RCA); Field failure evaluation; Market complication surveillance; Identify system complications; Drive process optimization
Required to climb or stoop, kneel, crouch or crawl, Required to regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds, Required to possess specific visons abilities, close vision, distance vision, color vision, peripheral vision, depth perception, capacity to adjust focus
What They're Looking For.
Must Have
1-3 years of design engineering experience, Bachelor's or master's degree in a biomaterials or related biomedical field, Demonstrated self-starting skills, Ability to manage multiple projects simultaneously, Well organized, detail oriented, team player capable of meeting deadlines, Highly skilled in designing and executing experiments, good lab steward
Nice to Have
design engineering experience preferably in the tissue engineering field, Experience or familiarity with a cGMP environment, manufacturing human cells, biologics, biomaterials, other product intended for human use
What You'll Do.
Engineering functions of existing product lines
Continuous improvement ideation
Design line extensions
Develop line extensions
Manufacturing improvements
Post launch monitoring
Field failure evaluation
Market complication surveillance
Ensure high quality of all products
Plan preclinical studies
Design preclinical studies
Execute preclinical studies
Evaluate tissue-based biomaterials
Evaluate tissue-based systems
Analyze experimental data
Analyze statistical data
Generate technical reports
Lead RCA investigations
Perform design verification
Perform validation activities
Develop project documentation
Maintain project documentation
Maintain batch records
Maintain technical files
Maintain detailed project plans
Ensure milestone adherence
Monitor post-launch product performance
Collect field feedback
Implement continuous improvement initiatives
Track performance data
Trend performance data
Identify system complications
Drive process optimization
Ensure compliance with quality systems
Ensure compliance with regulatory standards
Present technical findings
Present risk assessments
Present project updates
Uphold company Code of Conduct
Maintain compliance with AdvaMed Code
Maintain compliance with MedTech Code
Maintain compliance with governmental regulations
How You'll Work.
Team & Collaboration
Work with field staff; Collaborate cross-functionally with manufacturing; Collaborate with quality; Collaborate with donor services; Collaborate with distribution; Collaborate with supply chain teams; Present updates to cross-functional teams; Present updates to leadership; Value every person on our team; Treat each other with respect; Accountable to one another; Support each other
Communication Scope
Present technical findings; Present risk assessments; Present project updates
Process & Methodology
Maintain detailed project plans, Ensure milestone adherence
Full Job Description
Bone Bank Allografts, a subsidiary of Globus Medical Inc., specializes in processing and distributing high-quality bone allografts for various medical procedures, including orthopedic, dental, and reconstructive surgeries. Our commitment to excellence, supported by Globus’ renowned engineering, drives our mission to advance patient care and medical innovation through precise and efficient allograft processing and distribution. _Position Summary:_ The Sustaining Engineer will be responsible for engineering functions of existing product lines. This includes but is not limited to, continuous improvement ideation, design and development of line extensions, manufacturing improvements, post launch monitoring such as field failure evaluation, and market complication surveillance. This individual will work with field staff and all other functions of the company to ensure the high quality of all products continue throughout their lifecycles. _Essential Functions:_ * Plan, design, and execute preclinical and laboratory studies to evaluate tissue-based biomaterials and systems. * Analyze experimental and statistical data to generate technical reports and support data-driven strategic decisions. * Lead Root Cause Analysis (RCA) investigations and implement Corrective and Preventive Actions (CAPA). * Perform design verification and validation activities to ensure products meet defined specifications and regulatory requirements. * Develop and maintain project documentation including SOPs, protocols, reports, batch records, Design History Files (DHF), and technical files. * Maintain detailed project plans and ensure milestone adherence throughout the product lifecycle. * Collaborate cross-functionally with manufacturing, quality, donor services, distribution, and supply chain teams to support product development and lifecycle management. * Monitor post-launch product performance, collect field feedback, and implement continuous improvement initiatives. * Track and trend performanc
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