Senior Principal Scientist – Device Technical and Engineering Lead (Sr. Director Equivalent)
Our company’s DeviceProduct & ProcessDevelopment (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. The DPPD 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 injection.
This position will be responsible forapplying their knowledge of product and process development in the (bio)pharmaceutical and/or medical device industries to set tactical and strategic direction on programs they lead to ensure high quality products and robust manufacturing processes. This position interacts extensively with subject-matter experts on the DPPD 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 willleadcross-functional development teamswithinand external toDevice Development& TechnologyThe 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 their knowledgeofproduct design and development;manufacturingprocess development, qualification, and validation;anddesign control and risk management techniques to positively support and influenceclinical and commercialcombination product developmentand launches
Principal Responsibilities
Lead and set direction for the device development strategy formultipledrug-device combination productdevelopment programs ranging from concept generation/selection, development,verification, and validation tolaunch readiness:
Lead the cross-functional Device Working Groupsto ensure full integration of the device development activities with the clinical, regulatory, formulation, commercial and other key functions.
Lead the Device Development Engineering Core teamsfocused 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 Groupson 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 selecteddevice technology platforms.
Oversee and serve as a technical integrator ofall device development activitiesincludingengineering 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
Proactivelyanticipate andresolve project obstacles andeffectivelycommunicatecomplex product technical challenges,device development strategy,timelines, milestones, and riskswithinour Companyand 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.
Qualifications
REQUIREMENTS:
Required Skills:
Biopharmaceutical Industry, Biopharmaceutical Industry, Biopharmaceuticals, Clinical Development, Clinical Strategy, Clinical Supply Chain Management, Combination Products, Design Verification Testing, Development Projects, Device Development, Engineering Analysis, FDA Medical Device Regulations, Human Factor Engineering, Injection Moldings, Job Descriptions, Machine Learning (ML), Manufacturing Processes, Medical Device Regulations, Medical Devices Design, Medical Product Development, Motivation Management, Process Manufacturing, Production Process Development, Product Lifecycle Management (PLM), Regulatory Submissions {+ 1 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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The salary range for this role is
$173,200.00 - $272,600.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
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
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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
Domestic
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Hybrid
Shift:
Not Indicated
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
07/27/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
