Associate Director, Device Technology
Associate Director, Device Technology
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$ 139600 - 219700
1 Vacancy
Job Description
Job Description
Job Summary:
The Associate Director of Device Technology is a key leadership role within the Device Development and Technology Organization. This position is responsible for building strategic leadership technical expertise and managing external partners in the scaleup 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 be a technical subject matter expert on the device components and combination products and lead a cross functional team members to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the companys business goals and quality and regulatory compliance.
Essential Duties and Responsibilities:
Utilize extensive experience in design controls device transfer control strategies device risk management and design verification testing to develop valueadded solutions for medical devices and combination products.
Provide support for the external partner component manufacturing release and distribution to global manufacturing sites.
Identifying issues with minimal signals problem solving identification of root cause provide solutions.
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 governances
Support responses regulatory agency questions and preapproval inspections during a product development and life cycle management
Develop and execute strategic plans for technology transfer problemsolving leading teams in late stages of development and working collaboratively with external and internal partners.
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.
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
Lead mentor and enable the team to function as independent contributors providing support for global and sitespecific projects related to combination products and drug delivery systems.
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 ISOand other relevant quality management systems.
Qualifications:
Bachelors degree in mechanical engineering Biomedical Engineer or a related a technical field (e.g. Chemical Engineering Materials Engineering) required; advanced degree (Masters or PhD) preferred.
Minimum of 8 years of experience in pharmaceutical biologic medical device or combination product engineering with at least 4 years in managing external partners and suppliers.
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.
Demonstrated technical leadership in injection molding automation complex assembly and packaging operations for medical device or combination product component manufacturing with experience in autoinjectors prefilled syringes and complex drug delivery systems.
Exceptional project management skills and principled verbal and written communication abilities and prior experience leading combination product development teams and working groups
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.
Learn more about your rights including under California Colorado and other US State Acts
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.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$139600.00 $219700.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
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 preexisting 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:
YesTravel Requirements:
25%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/14/2025*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
