Associate Principal Engineer, Drug-Device Combination Products
Merck
Summary
This position is in the Device Development & Technology (DD&T) group in the Research division, responsible for the development of devices, combination products, processes, testing and assembly equipment from conception through product launch. Products include autoinjectors, inhalers, implants, infusion pumps, vaginal rings and connected devices/apps.
Job description
The DD&T Team is seeking a hands-on medical device product manufacturing and assembly engineer responsible for hands-on factory floor work and collaboration, interfacing with internal sites, medical device suppliers and sub-suppliers, including small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers and purchased device component suppliers.
Key Responsibilities
- Develop detailed plans and strategies for combination product assembly process and equipment development and lead technical team to deliver a qualified process and equipment for clinical or commercial use
- Author design/process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality
- Design and author process validation activity and documentation like IQ, OQ, PPQ etc.
- Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs
- Design automated combination product assembly equipment and manage equipment suppliers
- Develop, implement and troubleshoot combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems
- Manage all aspects of manufacturing site readiness including equipment qualification requirements and all associated documentation
- Apply understanding of device and combination product DFM/DFA principles and design and failure modes in relation to assembly processes
- Support process and technology transfer to manufacturing facilities
Preferred Experience and Skills
CAD design, including knowledge of SOLIDWORKS and 3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing.
Requirements
- B.S. Degree in Mechanical Engineering or related field
- Minimum 15 years of regulated industry experience
- Ability to develop detailed plans and strategies for combination product assembly process and equipment development and lead technical team
- Experience authoring design/process FMEA and identifying risk controls
- Experience designing and authoring process validation documentation (IQ, OQ, PPQ)
- Experience authoring protocols, reports, drawings and specifications per SOPs
- Experience designing automated combination product assembly equipment and managing equipment suppliers
- Experience developing, implementing and troubleshooting combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems
- Experience managing manufacturing site readiness including equipment qualification requirements and documentation
- Understanding of device and combination product DFM/DFA principles and failure modes in relation to assembly processes
- Excellent oral and written communication skills and ability to present complex information clearly
- Mechanical aptitude and hands-on troubleshooting skills
- Ability to work independently in a laboratory and manufacturing floor setting
- Strong interpersonal skills and ability to collaborate in a team environment
- High level work ethic
- Preferred: CAD design including SOLIDWORKS and 3D printing
- Preferred: ability to prototype and fabricate custom fixtures for assembly and testing
Benefits
- Medical, Dental & Vision
- Retirement Benefits
- 401(k)
- Paid Holidays
- Vacation
- Compassionate & Sick Days
- Annual Bonus
- Long-Term Incentive
Company overview
Merck & Co., Inc., known as Merck in the United States and Canada and MSD (Merck Sharp & Dohme) internationally, is a premier American multinational pharmaceutical company headquartered in Rahway, New Jersey. Founded in 1891 as the U.S. subsidiary of the German Merck Group, the company became independent following World War I and has since grown into one of the world's largest biomedical companies, ranking fourth globally by revenue. Merck operates across three core business segments: pharmaceuticals, vaccines, and animal health products. The company is renowned for its groundbreaking research and development, having brought numerous life-saving medicines to market including Keytruda (pembrolizumab), a leading immunotherapy for cancer treatment that generated $29.5 billion in 2024 revenue, and Gardasil, a revolutionary HPV vaccine. With approximately 75,000 employees worldwide, Merck maintains a robust pipeline of innovative therapies focused on oncology, vaccines, hospital acute care, cardiology, neuroscience, virology, immunology, and diabetes. The company invests heavily in R&D, spending $17.9 billion in 2024 alone, demonstrating its commitment to advancing scientific discovery. Merck's legacy spans over 130 years of bringing hope to humanity through important medicines and vaccines, operating with a purpose to use leading-edge science to save and improve lives globally while fostering an inclusive workforce and responsible business practices.