The Senior Engineer - Device Technical Operations position is a key engineering role within the Device Development and Technology Organization. This position is responsible for building strong engineering capabilities related to medical devices and combination products. The individual is also responsible for managing internal and external manufacturing in the development, scale-up, commercialization, and design transfer of medical devices and combination products, with a focus on complex drug-delivery systems such as autoinjectors, ophthalmic products, and inhalation products. The Senior Engineer - Device Technical Operations role is a technical subject matter expert on the device components, combination products, and processes to support global commercialization and technology transfer activities and drive product robustness for sustained launch in alignment with the company’s business goals, and quality and regulatory compliance., * Utilize extensive experience in design controls, design transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.

• Provide support for internal and external component manufacturing and combination product manufacturing, globally.
• Identify issues with minimal signals, problem solving, identification of root cause provides solutions.
• Build design engineering mindset for medical devices or combination products in both development and lifecycle management, ensuring compliance with relevant regulatory standards.
• Use engineering best practices and tools to optimize the design and manufacturing to ensure robust technical and programs decisions through the development and commercialization teams
• Support responses regulatory agency questions and pre-approval inspections during product development and life cycle management
• Develop and execute strategic plans for technology transfer, problem-solving, leading teams in late stages of development, and working collaboratively with external and internal partners.
• Foster a culture of inclusion by integrating inputs and perspectives from various sources to meet customer and stakeholder needs.
• Build strategic partnerships with manufacturing sites and partner groups
• Ensure that all activities are conducted with the highest regard for safety, quality, and regulatory compliance, aligning with the company’s divisional and local site procedures.
• Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master’s or PhD) preferred.
• Minimum of 5 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 2 years supporting commercial manufacturing
• Proven expertise in design controls, risk analysis, control strategies, design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance.
• Demonstrated technical experience in injection molding, automation, complex assembly and packaging operations for medical device or combination product component manufacturing. Direct experience in autoinjectors, ophthalmic products, or inhalation products highly preferred.

PRD

eligibleforERP, Construction Processes, Design Controls, Deviation Management, Driving Continuous Improvement, Engineering Leadership, Engineering Support, Ethical Compliance, GMP Documentation, Materials Science, Mechanical Engineering, Performance Monitoring, Process Development Engineering, Product Engineering, Root Cause Identification, Technology Development

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.