Job Title Clinical Validation Lead Job Description Clinical Validation Lead (Cambridge, MA) You will be part of a Breakthrough Innovation Team (BRITE) in the Innovation & Strategy Department reporting to Director, Clinical Innovation and supporting the development of groundbreaking robotic procedure automation solutions that will advance patient outcomes, improve procedural efficiency, and position Philips as a leader in the targeted clinical segment. BRITE is the embodiment of Philips' approach to driving breakthrough innovation by accelerating innovation to nurture nascent projects from early innovation stage to full ability to scale. Your role: Lead design validation activities to ensure that the product conforms to defined user needs and intended uses complying with Philips processes, industry standards and regulatory requirements. Create and update the validation plan, develop validation testing protocols including phantom, animal and clinical studies and execute validation studies following Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Evaluate and document validation testing results, work with stakeholders to implement the learnings from validation testing into product development and regulatory submission processes. Create and manage appropriate documentation as required by regulatory bodies (e.g., FDA, EUMDR, CMDE). Interface with cross-functional teams (e.g. R&D, Usability, Product Management, Quality, Regulatory) ensuring alignment of validation activities with the activities in these domains and managing dependencies within relevant processes. Define and document validation requirements and work with usability and R&D teams, product manager, system engineer and other relevant functions to translate validation requirements into test plan and protocols. Possess a deep comprehension of product development processes and validation expertise, adeptly assess whether to alter project scope or tackle challenges, prioritize tasks based on understanding the core challenge and continuously identify opportunities for improvement. Continuously communicate with clinical Key Opinion Leaders (e.g. physicians) and reflect their input into validation testing methodology, study protocols and study execution. Travel as needed up to 15%. You're the right fit if: You’ve acquired 5 plus years of experience with Bachelor's (OR Minimum 3 years of experience with Master's) in areas such as Clinical Development, Evaluation or Innovation or equivalent in Clinical Research, MedTech or Healthcare. You have experience in pre-clinical and clinical testing, wrote study protocols and reports with a strong understanding of compliance regulations. Experience in clinical/scientific evidence generation strategy, strategic planning and project management in clinical research, imaging or robotics device development in healthcare industry is preferred. Your skills include application of validation processes in healthcare/medical or other safety-critical/regulated areas (automotive, aviation, military, etc.) with expert knowledge of validation methodologies, processes and standards, particularly international standards and regulatory requirements (e.g. ISO, FDA, EU-MDR, CMDE). You also have a strong understanding of Risk Management process (ISO 14971) and Quality System Regulations (QSR); Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) processes; as well as working knowledge or experience in regulatory submissions in US, EU or other geographies. You are a great communicator with collaboration and execution skills to perform with multidisciplinary and international teams. Your mindset is entrepreneurial, and you have a track record of working on pioneering innovations. You are a self-starter pro-active thinker who contributes to a high-performance team in a dynamic environment. You have an affinity for (complex) medical devices and pre-clinical and clinical validation methods. You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Clinical position. You have a deep commitment to safety, quality and regulatory compliance in all aspects of your work. You excel at collaborating with cross-functional teams to mitigate risks in an agile, iterative manner. This is an office role. How we work together We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others. Learn more about our business. Discover our rich and exciting history. Learn more about our purpose. Learn more about our culture. Philips Transparency Details The pay range for this position in (Cambridge, MA) is $139,000 to $223,000 The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here. At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case. Additional Information US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future. Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Cambridge, MA. #LI=PH1 This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life. For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health. Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success. It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism. To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance. Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace. Know Your Rights
