Principal Scientist, Drug/Device Combination Products

* Lead/Support continuous improvement initiatives for design control and risk management processes* Identify and eliminate process inefficiencies using operational excellence tools* Develop training materials to foster a culture of operational excellence* Ensure processes align with regulatory requirements for medical device and drug combination products (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 14971)* Collaborate with cross-function teams to improve processes related to device-drug integration.* Partner with Quality and Regulatory teams to ensure compliance with applicable global regulations.* Leverage data analytics and key performance indicators to monitor process performance.* Support internal audits, regulatory inspections, and third-party audits.* Conduct structured assessments of key quality and compliance programs to identify gaps against internal standards, regulatory expectations (e.g., FDA, EMA), and industry best practices, generate action plans and drive the plan to closure. Develop actionable remediation plans and drive their execution through to closure.* Lead/contribute to device development, design controls for the assigned projects.* Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.* Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.* Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.* 10+ years of experience in process improvement, Quality management system, operational excellence, and product development* Has broad knowledge of combination product/medical device development, design controls, and risk management* Hands-on experience with combination products* Proven track record of driving lean and six sigma initiatives in a regulated environment* Led and managed development of DHF (design history file) deliverables for combination products and/or medical devices* Knowledge of U.S. and global combination product/medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.* Self-motivated with the ability to work independently.* Experience with FMEA, statistical sampling, and control strategy.* Proven ability to work with team members of diverse skill sets and backgrounds.* Strong analytical and problem-solving abilities.* Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.* Demonstrated experience leading and supporting change initiatives, with a strong track record of driving process improvements and fostering cross-functional collaboration to achieve sustainable results.* Excellent communication, presentation, negotiation, project management, and organizational skills.* PMP or similar project management certification* Quality Engineering Certification* Six Sigma Certification* Experience with device design, process development, design verification, and design validation**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance #J-18808-Ljbffr