Senior Scientist - Design Control (Hybrid)

MSD Malaysia; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays and vacation

Job summary

Merck & Co., Inc. in Rahway, NJ is seeking a Senior Scientist, Device Design Control Lead to drive design controls across combination product development, commercialization, and lifecycle management. You will collaborate with cross-functional teams and external suppliers to ensure high-quality products and efficient manufacturing.

The role requires leadership in risk assessment and regulatory compliance. Responsibilities include leading design controls, preparing regulatory materials, and

Qualifications

• 6+ years of related experience in pharmaceutical development, device development, device systems operations, quality management, or 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.

Responsibilities

• Lead and contribute device development design controls for assigned projects.
• Prepare materials for program presentations for management review and regulatory submissions.
• Lead the implementation of the device development strategy and design controls while adhering to plans and policies.
• Proactively resolve project obstacles and communicate strategy to stakeholders, including external suppliers.

Skills

Analytical Method Development

External Partners

GD&T

ISO 13485

Manufacturing Processes

Mechanical Design

Mechanical Testing

Method Validation

Product Development

Prototyping

Statistical Analysis

Teamwork

Technical Writing

Education

B.S. or M.S. in Engineering/Science

Job description

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:

• 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.

Required Skills:

• Analytical Method Development
• External Partners
• Geometric Dimensioning And Tolerancing (GD&T)
• ISO 13485 Medical Devices
• Manufacturing Processes
• Mechanical Design
• Mechanical Testing
• Method Validation
• Product Development
• Prototyping
• Statistical Analysis
• Teamwork
• Technical Writing

Equal Employment Opportunity

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.

Diversity and Inclusion

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.

Salary Range

The salary range for this role is $117,000.00 - $184,200.00 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.

Benefits

• 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

Other Compensation

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Job Location and Arrangement

• Employee Status: Regular
• Relocation: Domestic
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Hybrid
• Shift: Not Indicated
• Valid Driving License: No
• Hazardous Material(s): n/a

Legal Eligibility

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.

Job Posting End Date

Job Posting End Date: 10/12/2026

Employer

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC.