Associate Director, Drug/Device Combination Products (Hybrid)
Associate Director, Drug/Device Combination Products (Hybrid)
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$ 139600 - 219700
1 Vacancy
Job Description
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 companys 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 products globally.
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 compliance with 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 development standpoint
Stakeholder Collaboration and Communication:
Secure early sponsorship and stakeholder alignment for projects and initiatives effectively communicating decisions and expectations to key stakeholders 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 companys divisional and 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
8 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 component manufacturing 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 of quality management systems and regulatory compliance.
Exceptional project management skills and principled verbal and written communication abilities and experience collaborating with combination product development teams and working groups.
#eligibleforERP
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
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 other applicable legally protected a federal contractor 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:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; 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. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The salary range for this role is
$139600.00 - $219700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Biomedical Engineering Biomedical Engineering Chemical Engineering Communication Design Controls Design Engineering Design Thinking Design Verification Drug Delivery Leading Project Teams Management Process Manufacturing Methodologies Materials Engineering Mechanical Engineering Medical Device Management Medical Devices Medical Devices Design Medical Product Development People Management Product Commercialization Product Design Product Development Design Project Management Prototyping Regulatory Compliance 4 morePreferred Skills:
Job Posting End Date:
06/26/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
