Sr. Product Development Engineer, R&D

Skip to main content Sr. Product Development Engineer, R&D Onkos Surgical Parsippany, NJ Apply Sr. Product Development Engineer, R&D Onkos Surgical Parsippany, NJ 5 days ago 73 applicants See who Onkos Surgical has hired for this role Apply Save Report this job Job SummaryThe Onkos Surgical Senior Product Development Engineer serves as a lead project engineer responsible for all phases of the design, development, and regulatory clearance of antibacterial coatings and advanced surface treatments on surgical implants, from concept through commercialization. This role leads platform programs that combine coating and materials chemistry, analytical characterization, biocompatibility, verification and validation, process development, and regulatory strategy. The role also encompasses establishing and scaling R&D and characterization capabilities, supporting manufacturing transfer and process validation, contributing to the intellectual property portfolio, and advancing the quality system and other company initiatives.  ResponsibilitiesAdhere to Onkos Core Beliefs, Code of Business Conduct, all regulatory requirements and quality standards. Support company advocacy initiatives to help raise awareness of sarcoma and pediatric cancer and drive positive change that will impact the lives of cancer patients. Serve as lead project engineer for antibacterial coating and surface treatment platform programs, preparing and managing comprehensive project plans, resource requirements, project budgets, and timelines. Lead the development and optimization of implant coatings and surface treatments, including chemistry selection, coating process definition, and optimization of the process for quality, manufacturability, inspectability, and cost. Lead and execute product testing needed for regulatory clearance, from early bench and prototype evaluation through final verification and validation per the Onkos Quality System, including mechanical, biocompatibility, sterilization, packaging, and stability testing. Develop, validate and scale R&D coating and analytical characterization capability, translating process control parameters into manufacturing process validation. Interface with sales force, surgeons, and other stakeholders to understand customer needs in order to define design inputs, draft product performance requirements, and draft surgical techniques. Facilitate manufacture of prototypes and test articles. Plan and support biocompatibility and preclinical study programs, including protocol development and coordination of animal and toxicology studies per ISO 10993. Partner with the regulatory team, outside development partners, and testing vendors to fulfill submission requirements and to establish and execute development and testing timelines. Support manufacturing transfer and production start-up, including equipment qualification (IQ, OQ, PQ), operator training, and design transfer. Contribute to the intellectual property portfolio, generate design controls, risk management documentation, and other technical memos, conducting root cause and engineering analyses as necessary. Support quality, regulatory, and marketing initiatives that require engineering assistance, analyses and quantitative assessments of markets and products. Assist in developing innovative manufacturing and processing techniques and/or seek out new technologies for materials and processing through 3rd party...