Job Description
The Associate Director– Device Tech Transfer is a leadership role within the Device Development and Technology Organization. This position is responsible for providing strategic program leadership, technical expertise, and project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Associate Director will collaborate with a team of engineers and technical staff to support global and site-specific projects, facilitate technology transfer, and drive product robustness for sustained launch in alignment with the company's business goals, and quality and regulatory compliance.
Essential Duties and Responsibilities:
Program Leadership and Technical Project Management:
Provide program leadership in the development, commercialization, and transfer and sustained launch of medical devices and combination productsglobally.
Develop and execute strategic plans for technology transfer, problem-solving and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.
Provide Voice of Manufacturing input to early development teams to ensure needs of manufacturing are considered as part of the design. Provide information and drive early alignment and readiness reviews with manufacturing partners to assess speed, complexity, and requirements for commercializing new products.
Technical Expertise:
Utilize extensive experience in design controls, device transfer, control strategies device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.
Build and enhance device or combination product technology transfer programs in both development and lifecycle management, ensuring compliancewith relevant regulatory standards.
Ensure robust technical plans, risk communication, drive technical and programs decisions through the development team and governance forums
Author and complete regulatory filing sections, and support response to questions and pre-approval inspections from a product developmentstandpoint
Stakeholder Collaboration and Communication:
Secure early sponsorship and stakeholder alignment for projects and initiatives, effectively communicating decisions and expectations to keystakeholders and sponsors.
Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
Build strategic partnerships with manufacturing sites and partner groups
Regulatory Compliance and Quality Assurance:
Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company's divisionaland local site procedures.
Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971, and other relevant quality management systems.
Qualifications:
Education
Required | Technical BS degree or higher
Preferred | BS or Masters in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Materials Engineering, or similar
Experience
10+ years of experience in medical device or combination product engineering.
Demonstrated technical leadership in Technology Transfer and Design Transfer for medical device and combination product componentmanufacturing, assembly, and packaging, with specific experience in autoinjectors, prefilled syringes, and complex drug delivery systems.
Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding ofquality management systems and regulatory compliance.
Exceptional project management skills and principled verbal and written communication abilities, and experience collaborating with combinationproduct development teams and working groups.
Required Skills:
Commercialization, Design Controls, Design Engineering, Design Verification, Manufacturing Compliance, Manufacturing Methodologies, Materials Engineering, Medical Devices, Medical Devices Design, Medical Product Development, Product Design, Product Development Design, Project Management, Prototyping, Regulatory Compliance, Regulatory Inspections, Stakeholder Management, Technical Leadership, Technology Transfer
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
US and Puerto Rico Residents Only:
The salary range for this role is
$142,400.00 - $224,100.00
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 .
You can apply for this role through (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
Search Firm Representatives Please Read Carefully
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:
07/28/2026
*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.
