Associate Principal Scientist, Device Risk Management Lead (Associate Direc at Merck Sharp & Dohme Corp. /Netherlands

Upper Gwynedd Township, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Mar, 26

Salary

219700.0

Posted On

13 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Device Risk Management, Risk Assessments, Regulatory Compliance, Statistical Analysis, Cross-Functional Collaboration, Problem-Solving, Quality Management, FMEA, ISO 14971, Design Transfer, Post-Market Surveillance, Clinical Evaluations, Risk Control Measures, Mentoring, Communication, Leadership

Industry

Pharmaceutical Manufacturing

Description

Job Description The Associate Principal Scientist, Device Risk Management Lead, is a crucial member of our team, responsible for spearheading risk management efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device risk management activities to ensure the delivery of high-quality products and efficient manufacturing processes. The role requires extensive collaboration with subject-matter experts across various cross-functional combination product development teams throughout all phases of the product lifecycle, from concept through launch and post-market surveillance. Key Responsibilities and Activities: The Associate Principal Scientist, Device System – Device Risk Management will be responsible for device risk management activities in the following aspects: Lead and contribute to thorough risk assessments for both inline and new products, guiding projects from early design concept through commercialization and post-market evaluation. Develop and execute the device risk management strategy, including the creation of device risk management plans and reports, conducting system hazard analyses and Failure Modes and Effects Analysis (FMEA), implementing risk control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with corporate policies and communicate effectively with cross-functional stakeholders and external suppliers. Support Design Transfer activities to internal and external sites ensuring proper translation and implementation of risk control measures. Analyze information from post-market surveillance, clinical evaluations, and real-world evidence to inform risk management decisions and strategies. Utilize statistical methods to interpret risk data, providing clear and actionable recommendations rooted in empirical evidence. Work collaboratively with cross-functional teams to embed risk management processes into the overall product development lifecycle. Proactively identify and address project challenges, effectively communicating risk management strategies within the Device Development team and with external partners. Understand and apply regulatory and compliance requirements relevant to device risk management activities, ensuring adherence to industry standards. Lead risk management workshops and training programs, facilitating knowledge transfer for internal and external manufacturing sites to strengthen awareness of risk management principles across teams. Mentor junior risk management leads and cross-functional partners to promote best practices. Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness. Contribute to the development, implementation, and continuous enhancement of device risk management processes, procedures, and tools. Enhance the company’s professional image and competitive position through publications, presentations, patents, and active participation in professional activities. Stay informed of regulatory changes and industry best practices to maintain the effectiveness and relevance of our risk management strategies, sharing this knowledge with others in the organization. Participate in the strategic development of the Device Risk Management function, contributing to team goals and initiatives. Minimum education required: B.S and Master's degree in Engineering, Science, Business, or a related field plus 8 years of related experience. Required experience and skills: Minimum of 8 years of experience in pharmaceutical development, device development, device systems operations, quality management, or a related area. Strong knowledge of regulatory requirements and industry standards related to device systems. Strong analytical and statistical skills with experience in data interpretation and risk assessment tools. Excellent communication, leadership, and problem-solving skills. Ability to work in a dynamic and fast-paced environment, managing multiple priorities effectively. Required Skills: Combination Products Preferred Skills: 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 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: EEOC Know Your Rights EEOC GINA Supplement 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. 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 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 - $219,700.00 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 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 01/5/2026 *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. Requisition ID:R378042

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Responsibilities

The Associate Principal Scientist will lead device risk management activities throughout the product lifecycle, ensuring high-quality product delivery and compliance with industry standards. This includes conducting risk assessments, developing risk management strategies, and collaborating with cross-functional teams.