About this opportunity
MSD Malaysia lists this Senior Engineer, Device Technical Operations (Hybrid) opportunity in rahway, New Jersey. Review the employer’s description below for duties, qualifications and application requirements.
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 , 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
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.
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Worksite address
rahway, NJ, 07065, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.