Sr Engineer, Sustaining
Responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, which includes but not limited to the following:
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. Qualifications The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:
PhD Degree in Engineering (preferably Biomedical), or related field, or possess the equivalent combination of education and experience 5
years of medical device industry experience, preferably in a sustaining engineering position 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 The ability to travel up to 15%
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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. Qualifications The requirements listed below are representative of the knowledge, skills, and/or abilities required for this position:
PhD Degree in Engineering (preferably Biomedical), or related field, or possess the equivalent combination of education and experience 5
years of medical device industry experience, preferably in a sustaining engineering position 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 The ability to travel up to 15%
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
|
|
 | |
