Senior Engineer, Device Technical Operations (Hybrid)

MSD; Pennsylvania; Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Health, dental, vision insurance

Retirement benefits (401(k))

Paid holidays

Vacation

Sick days

Job summary

Merck & Co., Inc. in Rahway, NJ / West Point PA area seeks a Senior Engineer to lead Device Technical Operations in a hybrid role. You will manage design transfer, risk control, and verification for medical devices and combination products, advancing autoinjectors, ophthalmic, and inhalation systems.

Collaboration with internal and external sites is required. The role requires a mechanical/biomedical background, 5+ years in pharma/medical devices, and experience with ISO 13485 and ISO 14971.

Qualifications

• Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field; 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; strong regulatory compliance knowledge.
• Direct experience in autoinjectors, ophthalmic products, or inhalation products is highly preferred.

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 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 related technical field

Tools

Injection molding

Automation

Complex assembly and packaging operations

Job description

Senior Engineer, Device Technical Operations (Hybrid)*This site uses cookies to provide you with an optimal user experience. The cookies include Strictly Necessary and Functional cookies to ensure the site operates as intended (language preference, time zone and workload balance). These cookies are first party cookies, end with the session and are exempted from consent. In addition, this site also uses a Google Analytics Cookie to measure and improve the performance of our site. All information these cookies collect is aggregated and therefore anonymous. By clicking on the ‘Accept Cookies’ button, you are accepting this Performance cookie. You may use this site if you click on the ‘Reject Cookies’ button. To revoke your consent of the Performance cookie, clear your cookies within your browser settings.*### Senior Engineer, Device Technical Operations (Hybrid)Apply: Hybrid: USA - Pennsylvania - West Point: USA - New Jersey - Rahway: Full time: Posted Today: End Date: October 29, 2026 (6 days left to apply): R416761**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.# PRD# eligibleforERP**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:**Current Employees apply HERECurrent Contingent Workers apply HERE**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. Please click here if you need an accommodation during the application or hiring process.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 RightsEEOC GINA SupplementWe 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 The primary location for this posting is:USA - Pennsylvania - West Point Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is:$117,000.00 - $184,200.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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. **Additional location(s):** Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. **Additional location(s) Compensation Information:****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**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:**10/29/2026**\\*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.**