Senior Engineer, Device Technical Operations (Hybrid)

Merck & Co.; West Point (PA); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Paid holidays

Vacation

Sick days

Long-term incentive

Job summary

Merck & Co. is seeking a Senior Engineer to lead Device Technical Operations within the Device Development and Technology Organization. You will help build capabilities for medical devices and combination products, manage internal/external manufacturing, and drive design transfer for complex drug-delivery systems.

This role emphasizes safety, quality, and regulatory compliance. You will work on autoinjectors, ophthalmic and inhalation products, and partner with global teams to ensure robust

Qualifications

• Bachelor's degree in mechanical or biomedical engineering or related field.
• 5+ years in pharma, biologics, medical devices, or combination products.
• Experience with design controls and regulatory compliance.

Responsibilities

• Apply design controls, design transfer, and verification testing for devices.
• Support internal and external component and device manufacturing globally.
• Identify root causes and implement robust corrective actions.
• Lead development and lifecycle management for medical devices and combos.
• Ensure compliance with GMP, ISO 13485, and regulatory standards.
• Collaborate with partners to plan technology transfer and scale-up.

Skills

Design Controls

Risk Analysis

Process Validation

Injection Molding

Automation

Regulatory Compliance

Engineering Leadership

GMP Documentation

Materials Science

Mechanical Engineering

Education

Bachelor's in Engineering

Master's or PhD preferred

Job description

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

US and Puerto Rico Residents Only

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Equal Employment Opportunity Statement

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.

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.

Salary

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. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

Benefits

The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable.

• 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 .

Legal and Compliance

• Visa sponsorship: No
• Travel requirements: 10%
• Valid driving license: No
• Hazardous material(s): n/a

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

Search Firm Representatives Please Read Carefully

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.

Employee Status

Regular

Relocation

No relocation

Flexible Work Arrangements

Hybrid

Shift

1st - Day

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.

Requisition ID

R416761