Job Summary

The 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.

Responsibilities

• Adhere 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 relationships.
• Consult with surgeons and sales force to identify potential solutions for difficult patient cases.

Requirements

• Passion to find solutions to our patients’ unmet clinical needs and to advocate for their cause.
• Bachelor’s degree in an engineering or life sciences discipline. Biomedical, Materials, Mechanical, or Chemical Engineering preferred. Advanced degree a plus.
• 5+ years of product development experience in the medical device field, preferably related to orthopaedic or other medical device coatings. Experience with surface coatings, materials characterization, or related technologies strongly preferred.
• Experience in securing FDA regulatory clearances (510(k), De Novo, or pre-submissions) a strong plus.
• Demonstrated experience with design controls, risk management, and verification and validation in a regulated environment.
• Working knowledge of biocompatibility evaluation (ISO 10993), sterilization, and process validation (IQ, OQ, PQ).
• Ability to apply engineering principles to solve problems and develop new products and techniques.
• Demonstrated ability with statistics and related product performance analysis.
• Knowledge of CAD software. SOLIDWORKS preferred.
• Experience with manufacturing transfer, supplier qualification, and raw material controls a strong plus.
• Must be self-motivated, able to work independently, and thrive in a fast-paced dynamic environment.
• Strong attention to detail, interpersonal skills, and oral and written communication skills.
• Must be willing to attend and participate in cadaveric product evaluations and attend surgery for observation and/or technical support.
• Travel requirement: Up to 20%.

About Onkos

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause.

At Onkos Surgical, we exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients.

At Onkos Surgical, we will:

• Find solutions to our patients’ unmet clinical needs and advocate for their cause.
• Partner with surgical oncologists through research, education and innovation, to treat their patients more effectively and more efficiently.
• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
• Fulfill our employees’ desire to make a difference in the lives of the patients they serve while achieving their own professional growth.
• Deliver value to our customers and shareholders.