Remote Sustaining Engineer
Insight Global
2021-10-29T09:54:09Z
Princeton
New Jersey
United States
Engineering
(No Timezone Provided)
Job Description
Insight Global is seeking Remote Sustaining Engineers for one of our largest Medical Device clients. Experience with tissue-based technologies or experience developing or refining biological implantable materials preferred. Experience in extracellular matrix processing with an understanding of the biological performance of collagen-based membranes in soft tissue, including but not limited to xenografts, allografts, natural matrices, and regenerative tissue desired. Experience in contributing to technical and cross-functional teams to advance project goals with notable impact on company objectives. Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing. Working knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices. Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes and assembly of medical components and devices. Lead technical and product-related sustaining activities using knowledge of biomaterials, Design Controls, engineering principles and compliance writing
Perform complex remediation activities using Design Controls principles, FDA, ISO and other guidance, new product development knowledge and our internal procedures. Understand and be able to execute the necessary steps to qualify a material or a process change in manufacturing using Design Controls and internal procedures to ensure the safety and efficacy of the product and compliance to regulations.
Adjudicate the manufacture of biomaterials and any changes to fully understand the ramifications of a proposed process or material change regarding the safety and efficacy of the affected product. Using Design Controls and internal procedures, execute line extensions and other smaller new product development activities. Provide technical support for product registrations using product knowledge and the scientific literature. Perform other sustaining activities that are required to ensure our products remain safe and efficacious and compliant with applicable regulations.
Minimum Requirements
4+ years experience as a Sustaining Engineer in the Medical Device Industry
Experienced with leading Design Specifications/Control, Change Control, Validation/Testing for R&D/New Product Development
U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes and assembly of medical devices
PhD in Engineering (preferably Biomedical) or related field or has equivalent years of experience
Open to 10-15% Travel
Desired Skills
Biocompatibility/Biomaterial Experience
Tissue Based Technology
Remote Sustaining Engineer
Job Description
Insight Global is seeking Remote Sustaining Engineers for one of our largest Medical Device clients. Experience with tissue-based technologies or experience developing or refining biological implantable materials preferred. Experience in extracellular matrix processing with an understanding of the biological performance of collagen-based membranes in soft tissue, including but not limited to xenografts, allografts, natural matrices, and regenerative tissue desired. Experience in contributing to technical and cross-functional teams to advance project goals with notable impact on company objectives. Experience in generating test plans, writing protocols, conducting design verification/validation, and processing validation testing. Working knowledge of the U.S. and International standards governing the design, development, testing, and manufacture of medical devices. Experience/familiarity with U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes and assembly of medical components and devices. Lead technical and product-related sustaining activities using knowledge of biomaterials, Design Controls, engineering principles and compliance writing
Perform complex remediation activities using Design Controls principles, FDA, ISO and other guidance, new product development knowledge and our internal procedures. Understand and be able to execute the necessary steps to qualify a material or a process change in manufacturing using Design Controls and internal procedures to ensure the safety and efficacy of the product and compliance to regulations.
Adjudicate the manufacture of biomaterials and any changes to fully understand the ramifications of a proposed process or material change regarding the safety and efficacy of the affected product. Using Design Controls and internal procedures, execute line extensions and other smaller new product development activities. Provide technical support for product registrations using product knowledge and the scientific literature. Perform other sustaining activities that are required to ensure our products remain safe and efficacious and compliant with applicable regulations.
Minimum Requirements
4+ years experience as a Sustaining Engineer in the Medical Device Industry
Experienced with leading Design Specifications/Control, Change Control, Validation/Testing for R&D/New Product Development
U.S. FDA, GMP, and ISO requirements for the design, validation, manufacturing processes and assembly of medical devices
PhD in Engineering (preferably Biomedical) or related field or has equivalent years of experience
Open to 10-15% Travel
Desired Skills
Biocompatibility/Biomaterial Experience
Tissue Based Technology