Principal Scientist, Drug/Device Combination Products – Merck – Jobs in Rahway, NJ | OpenJobs AI

Job Details

Overview Company

Principal Scientist, Drug/Device Combination Products

$153.8k/y-$242.2k/y

Merck

19 hours ago

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HybridFull-timeDirector

Summary

Merck is seeking a Principal Scientist, Drug/Device Combination Products to join their team in Rahway, NJ. The role involves leading and implementing medical device and combination product design controls from early design concept through commercialization.

About the Role

As a Principal Scientist, you will be responsible for leading continuous improvement initiatives related to design control and risk management processes for combination products. You will collaborate with cross-functional teams, ensure compliance with global regulatory requirements, and leverage data analytics to monitor process performance. Your role will also include supporting internal audits and conducting assessments of quality and compliance programs.

About You

Required:

B.A./B.S. in Mechanical Engineering, Biomedical Engineering, Industrial and System Engineering, or related field plus 15 years of experience, or a master's degree plus 12 years of experience.
10+ years of experience in process improvement, quality management systems, operational excellence, and product development.
Broad knowledge of combination product/medical device development, design controls, and risk management.
Hands-on experience with combination products.
Proven track record of driving lean and six sigma initiatives in a regulated environment.
Knowledge of U.S. and global combination product/medical device regulations.

Preferred:

PMP or similar project management certification.
Quality Engineering Certification.
Six Sigma Certification.
Experience with device design, process development, design verification, and design validation.

Benefits

Comprehensive benefits package including medical, dental, and vision healthcare.
Retirement benefits including 401(k).
Paid holidays, vacation, and compassionate and sick days.
Eligibility for annual bonus and long-term incentive.

Merck

At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com. This site is intended for residents of the United States and Canada and their territories only. FLS: http://merck.us/3TKXNuZ

Rahway, NJ