Senior Engineer, Device Technical Operations (Hybrid)
Merck
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Job summary
Merck seeks a Senior Engineer - Device Technical Operations to build capabilities for medical devices and combination products. The role manages internal and external manufacturing for development, scale-up, and design transfer of devices with autoinjectors, ophthalmic and inhalation products.
The position requires deep expertise in design controls, risk management, and process validation, supporting regulatory inspections and technology transfer while driving product robustness for sustained
Qualifications
- Bachelor’s degree in engineering; advanced degree preferred.
- Minimum of 5 years in pharmaceutical, biologic, medical device or combination product engineering with at least 2 years supporting commercial manufacturing.
- Expertise in design controls, risk analysis, control strategies, design verification testing, and process validation with strong quality/regulatory knowledge.
- Experience in injection molding, automation, complex assembly and packaging for medical devices; autoinjectors, ophthalmic or inhalation products preferred.
Responsibilities
- Utilize design controls, design transfer, control strategies, device risk management, and verification testing to develop value-added solutions.
- Support internal and external component and combination product manufacturing globally.
- Identify issues from minimal signals; perform root cause analysis and implement solutions.
- Build design engineering mindset for medical devices in development and lifecycle management; ensure regulatory compliance.
- Use best practices to optimize design and manufacturing decisions across teams during development and commercialization.
- Support regulatory agency questions and pre-approval inspections during product development and life cycle.
- Develop and execute strategic plans for technology transfer and late-stage development; collaborate with internal and external partners.
- Foster inclusion by integrating inputs from diverse sources to meet customer needs.
- Build strategic partnerships with manufacturing sites and partner groups.
- Ensure safety, quality, regulatory compliance; align with site procedures.
- Support regulatory inspections and maintain ISO 13485, ISO 14971-2019, and other QMS.
Skills
Education
Job description
Senior Engineer - Device Technical Operations
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.
- 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
US And Puerto Rico Residents Only
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
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.
Learn more about your rights, including under California, Colorado and other US State Acts
$117,000.00 - $184,200.00
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
No relocation
No
10%
Hybrid
1st - Day
No
n/a
09/22/2026
R416761
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