Senior Engineer, Device Technical Operations (Hybrid)

MSD Malaysia; West Point (PA); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) retirement benefits

Paid holidays

Vacation

Compassionate and sick days

Job summary

Merck is seeking a Senior Engineer - Device Technical Operations to build engineering capabilities for medical devices and combination products, bridging development and manufacturing across global sites. The role focuses on autoinjectors, ophthalmic, and inhalation products with strong emphasis on regulatory readiness.

Responsibilities include design controls, risk management, and transfer activities, while ensuring quality, safety, and compliance.

Qualifications

• Bachelor's degree in mechanical engineering, biomedical engineering, or a related technical field required; advanced degree 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.

Responsibilities

• 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.

Skills

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

Education

Bachelor's degree in mechanical engineering, biomedical engineering, or a related technical field

Advanced degree (Master's or PhD) preferred

Job description

Job Title

Senior Engineer - Device Technical Operations

Job Summary

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.

Essential Duties and Responsibilities

• 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.

Qualifications

• 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.

Required Skills

• 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

Preferred Skills

• US and Puerto Rico Residents Only

Salary Range

The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

Location and Working Conditions

• San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
• Los Angeles Residents Only: 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.
• Employee Status: Regular
• Relocation: No relocation
• VISA Sponsorship: No
• Travel Requirements: 10%
• Flexible Work Arrangements: Hybrid
• Shift: 1st - Day
• Valid Driving License: No
• Hazardous Material(s): n/a

Job Posting End Date

Job Posting End Date: 09/22/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Company Overview

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.