Sr. Scientist, Drug/Device Combination Products, Design Controls (Hybrid)

Job Description

Job Description

The Senior Scientist, Device Design Control Lead, is a crucial member of our team, responsible for spearheading design control efforts in combination product development, commercialization, and lifecycle management. This individual will oversee device design control 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 Senior Scientist, Device System - Device Design Control will be responsible for device design control activities in the following aspects:

• Lead and contribute device development design controls for the assigned projects.-
  
• Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness.
  
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls for the assigned projects while adhering to management-approved strategic plans, corporate policies, and providing clear communication to cross-functional stakeholders, including external suppliers.
  
• Proactively resolve project obstacles and challenges and communicate device development strategy and design controls approach within Device Development and with external suppliers.
  
• Understand and apply regulatory / compliance requirements relative to design controls and risk management activities.
  
• Contribute to the development, implementation, and continuous enhancement of device design control processes, procedures, and tools.
  
• Participate in the strategic development of the Device Design Control function, contributing to team goals and initiatives.
  

Minimum education required:

• B.S or master's degree in Engineering, Science, or a related field plus 6 years of related experience.
  

Required experience and skills:

• Minimum of 6 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.
  

#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 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:

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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.

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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 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
$114,700.00 - $180,500.00

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:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Required Skills:
Analytical Method Development, Analytical Method Development, Business, Business Management, Creativity, Device Development, External Partners, Fast-Paced Environments, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Method Validation, Pharmaceutical Development, Product Commercialization, Product Development, Product Lifecycle, Prototyping, Quality Management, Risk Analysis, Risk Assessments, Risk Management, Science, Social Collaboration {+ 3 more}

-Preferred Skills:

Job Posting End Date:
09/19/2025
*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: R353881