Associate Director, Device TechnologyMSD Malaysia • Rahway, NJ, United States
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Associate Director, Device Technology
MSD Malaysia • Rahway, NJ, United States
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job_description.job_card.job_descriptionJob 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 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 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 company's 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 value-added 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 pre-approval inspections during a product development and life cycle management Develop and execute strategic plans for technology transfer, problem-solving, 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 site-specific 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 company's divisional and local site procedures. Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems. Qualifications : Bachelor’s degree in mechanical engineering, Biomedical Engineer, or a related a technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master's 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 groupsPSCS Required Skills : Business, Combination Products, Device Development, Drug Delivery, Injection Moldings, Management Process, Manufacturing Compliance, Medical Devices, Product Commercialization, Quality Management System Improvement, Regulatory Compliance, Regulatory Inspections, Social Collaboration, Strategic Leadership, Technology Transfer Preferred Skills : Current Employees applyCurrent Contingent Workers apply 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 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 characteristics. As 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 another’s thinking and approach problems collectively. 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 presence.This 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$139,600.00 - $219,700.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An 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
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Associate Technology • Rahway, NJ, United States
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