Associate Principal Scientist - Device Technical and Engineering Lead (Associate Director Equiv[...]

Our company's Device Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/drug/vaccine-device enabled combination products to achieve safe and effective delivery to the intended site of action. The DPPD Team manages the development of the device component of our company's pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and injection.Principal ResponsibilitiesLead and set direction for the device development strategy for multiple drug-device combination product development programs ranging from concept generation/selection, development, verification, and validation to launch readiness.Lead the cross-functional Device Working Groups to ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key company functions.Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT).Maintain engagement with Early Development Teams (EDT) and Product Development Teams (PDT).Serve as key point-of-contact with potential external device designers, developers, and suppliers for selected device technology platforms.Oversee and serve as a technical integrator of all device development activities including engineering design, engineering analysis and testing, medical device design controls, risk management, test method/fixture development, design verification and validation, injection molding, automated assembly, and human factors analysis.Proactively anticipate and resolve project obstacles and effectively communicate complex product technical challenges, device development strategy, timelines, milestones, and risks within our Company and with external suppliers.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.Lead/support/oversee clinical supplies production with respect to device component manufacture and final assembly of biologic/drug product with device constituent part.Lead/support the development, implementation and continuous improvement of Device Development and Device Project Leader processes, procedures, and tools.Maintain a high level of engagement in the program-specific design controls process and design history file development.Stay current with new device technologies, relevant worldwide regulations, standards, and effectively share this knowledge with others.Enhance our company's professional image and competitive advantage through publications, presentations, patents, and professional activities.Education RequirementsB.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering.Advanced degree is preferred.Required Experience and SkillsMinimum of 10 years of combined experience in medical device and combination product development.Leadership experience with working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes, including development of drug-device combination product or a medical device component of a combination product.Leadership experience of managing device or combination product development programs and leading cross-disciplinary project teams.Broad knowledge of medical device development, design controls and risk management, alongside deep knowledge in device design, requirement management, design verification, automation/process development, design validation, and control strategy.Knowledge of U.S. and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ISO 11608 and ISO 11040, EN 62366, Council Directive 93/42/EEC, etc.Proven track record of applying analytical skills in product design, development, and validation.Self-motivated with ability to work independently.Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership.Excellent communication, presentation, negotiation, project management, and organizational skills.Experience with leading complex development projects at an enterprise level.Willing to travel.Able to multi-task continuously.Required Technical SkillsCombination Products, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Verification Testing, Development Projects, Device Development, Human Factor Engineering, Manufacturing Processes, Medical Device Quality Systems, Medical Devices, Medical Devices Design, Product Design, Risk Management, Test Method Validation, Troubleshooting.BenefitsSalary range: $142,400.00 – $224,100.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits including medical, dental, vision, health insurance for employee and family, retirement benefits with 401(k) matching, paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will work a hybrid model consisting of three on-site days per week (Monday-Thursday) and a remote day on Friday, unless business critical tasks require on-site presence. This model does not apply to field-based positions, facility-based, manufacturing-based, research-based positions, positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work) or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Roles designated as "remote" are exempt from this model.Travel Requirements10% travel expected.EEO StatementAs an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. We comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights, EEOC GINA Supplement. We are proud to embrace a diverse workforce and encourage respectful collaboration.J-18808-Ljbffr