Merck
Senior Principal Device Technical Working Group Lead
Merck, Rahway, New Jersey, us, 07065
Job DescriptionOur company’s Device Development and Technology (DD&T) Team designs, develops, and commercializes novel biologic/drug/vaccine-device enabled combination products to achieve safe and effective delivery to their intended site of action. The DD&T Team manages the development of the device constituent of our company’s pipeline of combination products across a variety of therapy areas and routes of administration including inhalation, implantation, and parenteral delivery.Job DescriptionThis position will be responsible for applying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on the company’s highest complexity programs they are selected to lead to ensure high-quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DD&T team and members of internal cross-functional product development teams from concept through product launch. Additionally, the position will ensure products and processes are developed in accordance with applicable regulatory, quality, company, and customer requirements.This position will lead cross-functional development teams within and external to Device Development. The incumbent must be able to work well with all levels of employees and be able to effectively coordinate the execution of device development strategies. This individual will be expected to apply his/her knowledge of product design and development, manufacturing process development, qualification and validation, design controls, and device risk management techniques to positively support and influence clinical and commercial combination product development and launches.Principal ResponsibilitiesLead and set direction for the device development strategy for multiple development programs ranging from concept generation/selection through commercialization and launch readiness:
Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.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.Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, 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 select device technology platforms.
Maintain a high level of engagement in all device development activities (e.g. 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).Maintain a high level of engagement in the program-specific design controls process and design history file development.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.Manage and develop team members leading the internal engineering core teams.Remain current in relevant worldwide regulatory guidance and standards.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.Proactively resolve project obstacles and challenges and communicate device development strategy, design controls, and risk management approaches within Device Development and with external suppliers.Enhance our company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others.QualificationsRequirements:B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development.5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes, including development drug-device combination product or a medical device component of a combination product.Has broad knowledge of medical device development, design controls, and risk management, alongside deep knowledge in device design, requirement management, FMEA, design verification, design validation, statistical sampling, 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, 11608 and 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.Proven ability to lead team members of diverse skill sets and backgrounds.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 development projects at an enterprise level.Willing to travel.Able to multi-task continuously.
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Lead the Device Development Engineering Core teams focused on development of design requirements for the combination product and engineering execution against the established requirements.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.Represent Device Development and the project-specific Device Working Groups on cross-functional teams, including the Development and Commercialization Team (DCT). Additionally, 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 select device technology platforms.
Maintain a high level of engagement in all device development activities (e.g. 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).Maintain a high level of engagement in the program-specific design controls process and design history file development.Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under your leadership.Manage and develop team members leading the internal engineering core teams.Remain current in relevant worldwide regulatory guidance and standards.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.Proactively resolve project obstacles and challenges and communicate device development strategy, design controls, and risk management approaches within Device Development and with external suppliers.Enhance our company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.Stay current with relevant regulations, technologies, standards, and effectively share this knowledge with others.QualificationsRequirements:B.A./B.S in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or other types of engineering plus a minimum of 15 years of combined experience in medical device and combination product development.5+ years of leadership experience with deep working knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes, including development drug-device combination product or a medical device component of a combination product.Has broad knowledge of medical device development, design controls, and risk management, alongside deep knowledge in device design, requirement management, FMEA, design verification, design validation, statistical sampling, 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, 11608 and 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.Proven ability to lead team members of diverse skill sets and backgrounds.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 development projects at an enterprise level.Willing to travel.Able to multi-task continuously.
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