Merck
Senior Principal Scientist – Device Technical and Engineering Lead (Senior Direc
Merck, Rahway, New Jersey, us, 07065
Senior Principal Scientist – Device Technical and Engineering Lead (Senior Director Equivalent)
Our 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 their intended site of action. This role leads cross‑functional development of the device component across multiple therapy areas and routes of administration, including inhalation, implantation, and injection.
Principal Responsibilities
Lead and set direction for the device development strategy for multiple drug‑device combination product development programs from concept generation through launch readiness.
Lead the cross‑functional Device Working Groups to ensure full integration of device development activities with 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), and 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, 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 the company and with external suppliers.
Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under the incumbent’s leadership.
Lead/support clinical supplies production with respect to device component manufacture and final assembly of the 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 the company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.
Qualifications
B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or another engineering discipline with a minimum of 15 years of combined experience in medical device and combination product development. An advanced degree is preferred.
5+ years of leadership experience with deep knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes for drug‑device combination products or medical device components.
5+ years of leadership experience managing complex device or combination product development programs and leading cross‑disciplinary project teams.
Experience in development and commercialization of inhalation devices and/or autoinjectors is strongly preferred.
Broad knowledge of medical device development, design controls and risk management, and 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 product cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ISO 11608, ISO 11040, EN 62366, and EU Council Directive 93/42/EEC.
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 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 Skills
Business Development
Clinical Strategy
Clinical Supply Chain Management
Communication
Computer Science
Customer‑Focused
Design Verification Testing
Device Development
Ethical Compliance
Human Factor Engineering
Injection Molding
Intellectual Property Management
Interpersonal Relationships
Machine Learning (ML)
Manufacturing Processes
Medical Device Design Control
Medical Device Management
Medical Device Regulations
Medical Devices
Medical Product Development
Negotiation
Process Manufacturing
Product Design
Hybrid work model: Starting September 5, 2023, employees in U.S. office‑based positions will work a hybrid schedule with three on‑site days per week, Monday–Thursday (specific days may vary), and Friday as a remote‑working day unless business‑critical tasks require on‑site presence. The model does not apply to field‑based, manufacturing‑based, research‑based, or remote‑designated positions.
Salary range for this role: $169,700.00 – $267,200.00. Eligibility for annual bonus and long‑term incentive may apply. A comprehensive benefits package is also offered.
EEO Statement:
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other applicable legally protected characteristics. We are a federal contractor and comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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Principal Responsibilities
Lead and set direction for the device development strategy for multiple drug‑device combination product development programs from concept generation through launch readiness.
Lead the cross‑functional Device Working Groups to ensure full integration of device development activities with 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), and 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, 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 the company and with external suppliers.
Author and review relevant portions of the regulatory submissions (INDs, IMPDs, NDAs, BLAs, etc.) for combination product programs under the incumbent’s leadership.
Lead/support clinical supplies production with respect to device component manufacture and final assembly of the 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 the company’s professional image and competitive advantage through publications, presentations, patents, and professional activities.
Qualifications
B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or another engineering discipline with a minimum of 15 years of combined experience in medical device and combination product development. An advanced degree is preferred.
5+ years of leadership experience with deep knowledge of device, biologic/drug product, and process development including regulatory submission and approval processes for drug‑device combination products or medical device components.
5+ years of leadership experience managing complex device or combination product development programs and leading cross‑disciplinary project teams.
Experience in development and commercialization of inhalation devices and/or autoinjectors is strongly preferred.
Broad knowledge of medical device development, design controls and risk management, and 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 product cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, ISO 11608, ISO 11040, EN 62366, and EU Council Directive 93/42/EEC.
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 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 Skills
Business Development
Clinical Strategy
Clinical Supply Chain Management
Communication
Computer Science
Customer‑Focused
Design Verification Testing
Device Development
Ethical Compliance
Human Factor Engineering
Injection Molding
Intellectual Property Management
Interpersonal Relationships
Machine Learning (ML)
Manufacturing Processes
Medical Device Design Control
Medical Device Management
Medical Device Regulations
Medical Devices
Medical Product Development
Negotiation
Process Manufacturing
Product Design
Hybrid work model: Starting September 5, 2023, employees in U.S. office‑based positions will work a hybrid schedule with three on‑site days per week, Monday–Thursday (specific days may vary), and Friday as a remote‑working day unless business‑critical tasks require on‑site presence. The model does not apply to field‑based, manufacturing‑based, research‑based, or remote‑designated positions.
Salary range for this role: $169,700.00 – $267,200.00. Eligibility for annual bonus and long‑term incentive may apply. A comprehensive benefits package is also offered.
EEO Statement:
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other applicable legally protected characteristics. We are a federal contractor and comply with all affirmative action requirements for protected veterans and individuals with disabilities.
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