Senior Scientist - Design Control (Hybrid)

MSD • Rahway, NJ

2d • $117,000 - $184,200 • Hybrid

About The Position

The Senior Scientist, Device Design Control Lead, is responsible for leading device design control efforts in combination product development, commercialization, and lifecycle management. The role oversees device design control activities to support high-quality products and efficient manufacturing processes. It collaborates with subject-matter experts and cross-functional combination product development teams through all phases of the product lifecycle, from concept through launch and post-market surveillance.

The position leads and contributes to device development design controls for assigned projects; prepares materials for management reviews and regulatory submissions; and leads implementation or ensures effective execution of device development strategies and design controls in accordance with approved plans and corporate policies. The role communicates with cross-functional stakeholders and external suppliers, resolves project obstacles, applies regulatory and compliance requirements for design controls and risk management, improves design control processes and tools, and contributes to the strategic development of the Device Design Control function.

Requirements

• B.S. or master's degree in Engineering, Science, or a related field.
• At least 6 years of related experience.
• At least 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, including experience with data interpretation and risk assessment tools.
• Excellent communication, leadership, and problem-solving skills.
• Ability to work in a dynamic, fast-paced environment and manage multiple priorities effectively.
• Required skills include analytical method development, working with 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, and technical writing.

Responsibilities

• Lead and contribute device development design controls for assigned projects.
• Prepare materials for program presentations for management review and regulatory submissions.
• Lead implementation of, or ensure effective execution of, device development strategy and design controls for assigned projects, following approved strategic plans and corporate policies.
• Communicate device development strategy and design control approaches to cross-functional stakeholders and external suppliers.
• Proactively resolve project obstacles and challenges.
• Apply regulatory and compliance requirements related to design controls and risk management activities.
• Contribute to developing, implementing, and continuously enhancing device design control processes, procedures, and tools.
• Participate in strategic development of the Device Design Control function and contribute to team goals and initiatives.

Benefits

• Medical, dental, vision healthcare, and other insurance benefits for employees and families.
• Retirement benefits, including 401(k).
• Paid holidays, vacation, compassionate days, and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.
• Domestic relocation.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior