Lead Device Design Controls Scientist

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

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