Device Design Control Lead — Senior Scientist

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

Benefits offered by this job

Annual bonus

Long-term incentive

Job summary

Merck is seeking a Senior Scientist, Device Design Control Lead in Rahway, NJ, to drive design controls across combination product development from concept through lifecycle management.

The role requires guiding cross-functional teams, ensuring regulatory readiness, and delivering high-quality devices while aligning with corporate policies and supplier collaboration. Strong analytical, leadership, and communication skills are essential for success in a dynamic work environment.

Qualifications

• BS or MS in engineering/science with 6+ years of related experience.
• Experience in pharmaceutical/device development and regulatory requirements.
• Strong communication and leadership skills.
• Ability to work in a fast-paced environment with multiple priorities.

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 and execution of device development strategy and design controls, aligned with plans and policies.
• Proactively resolve project obstacles and communicate design controls approach within Device Development and with external suppliers.
• Understand and apply regulatory/compliance requirements related to design controls and risk management activities.
• Contribute to development, implementation, and improvement of device design control processes, procedures, and tools.
• Participate in strategic development of the Device Design Control function and team initiatives.

Skills

Analytical Method Development

External Partners

GD&T

ISO 13485 Medical Devices

Manufacturing Processes

Mechanical Design

Mechanical Testing

Method Validation

Product Development

Prototyping

Statistical Analysis

Teamwork

Technical Writing

Education

B.S. or Masters degree in Engineering, Science, or related field

Job description

Merck is seeking a Senior Scientist, Device Design Control Lead in Rahway, NJ, to drive design controls across combination product development from concept through lifecycle management.

The role requires guiding cross-functional teams, ensuring regulatory readiness, and delivering high-quality devices while aligning with corporate policies and supplier collaboration. Strong analytical, leadership, and communication skills are essential for success in a dynamic work environment.