Sr Engineer, Product Development
Responsibilities Reporting to the Director, R&D, the Sr Product Development Engineer is responsible for managing all aspects of design development and testing for medical devices and biologics at Integra in compliance with the FDA Quality System Requirement. These duties include developing medical device designs and prototypes, detailed specifications and tolerances, and test methods. They will apply knowledge of engineering to lead and technically support the development of medical devices. They utilize knowledge and expertise to resolve critical issues and successfully commercialize products. Employees in this role have had success as technical members of cross functional project teams and have the skills necessary to lead projects. Lead research and development activities using knowledge of anatomy/physiology, biomaterials, and basic engineering principles Develop design testing methods and procedures; conduct prototype and design verification as directed Prepare and present technical updates to the Tissue Technology leadership team Provide written documentation and reports for testing Mentor and direct other engineers in design development and testing for medical devices and biologics Participate in in-vitro and in-vivo studies, including animal and human evaluations as part of product development Update estimates, budgets, schedules, reports, and design control documents based on revisions and changes to the product designs and research projects Investigate design changes and failures, product complaints, and non-conformances; report findings and recommendations in company systems for corrective and preventive action Assist in preparing and maintaining the departmental policies, procedures, and manuals Submit new ideas for patent filing Prepare Failure Mode Effects Criticality Analysis (FMECA) and risk assessments for product and processes Assist in process/product validations of new and modified designs and processes Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the design, testing, documentation, and manufacturing of the company's products Generate test plans and reports in support of regulatory submissions Interface with Manufacturing, Quality, Regulatory, Research and Development, Sales, Marketing, and outside vendors to accomplish assigned tasks Performs related duties as assigned Qualifications Minimum of a Bachelor's degree in an Engineering discipline, or possess the equivalent combination of education and experience Minimum of 7 years of medical device industry experience, preferably in a product development engineering position Experience with tissue-based technologies or experience developing or refining biological implantable materials 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 (processing of materials)--natural, not synthetic desired Experience in developing and implementing procedures, methods, and tools for the manufacture or design and testing of medical products Experience in contributing to technical and cross-functional teams in accomplishing projects with notable impact(s) 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, secondary operations, and assembly of medical components and devices The ability to travel up to 15%
Salary Range:
$100K -- $150K
Minimum Qualification
Technical Product ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
Salary Range:
$100K -- $150K
Minimum Qualification
Technical Product ManagementEstimated Salary: $20 to $28 per hour based on qualifications.
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