Device Design Control Lead — Senior Scientist

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

Benefits offered by this job

Medical, dental, vision

Retirement benefits (401(k))

Paid holidays and vacation

Sick days

Job summary

Merck & Co., Inc., Rahway, NJ, USA is seeking a Senior Scientist, Device Design Control Lead to spearhead design controls for combination product development and lifecycle management. You will collaborate with cross-functional teams to ensure high-quality devices and efficient manufacturing throughout the product lifecycle, from concept through launch and post-market activities.

The role requires 6+ years in pharmaceutical or device development, strong regulatory knowledge, and proven analytical

Qualifications

• 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.

Responsibilities

• Lead and contribute device development design controls for the assigned projects.
• Prepare materials for program presentations for management review and regulatory submissions.
• Lead the implementation and/or ensure effective execution of the device development strategy and design controls
• Proactively resolve project obstacles 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.

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 master's degree in Engineering, Science, or a related field

Job description

Merck & Co., Inc., Rahway, NJ, USA is seeking a Senior Scientist, Device Design Control Lead to spearhead design controls for combination product development and lifecycle management. You will collaborate with cross-functional teams to ensure high-quality devices and efficient manufacturing throughout the product lifecycle, from concept through launch and post-market activities.

The role requires 6+ years in pharmaceutical or device development, strong regulatory knowledge, and proven analytical