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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Senior Engineer, Device Technical Operations (Hybrid) - **Company:** Merck Sharp & Dohme LLC - **Location:** Rahway, NJ, United States - **Experience:** Expert - **Salary:** $117,000.0 - $184,200.0 - **Contract:** Permanent contract - **Skills:** Adobe InDesign, Performance Monitor - **Published:** September 17, 2026 - **Apply:** https://dejobs.org/x/x/E771F522DEC249FA8B661803678D0DC2/job/ ## About the Role * 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, 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 ## Description 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. ## Related Videos - [Automate everything via NodeJS and Puppeteer](https://www.wearedevelopers.com/videos/322-automate-everything-via-nodejs-and-puppeteer) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [From Doubt to Confidence: How Sentry Uses Verdaccio to Bulletproof SDK Releases](https://www.wearedevelopers.com/videos/739-from-doubt-to-confidence-how-sentry-uses-verdaccio-to-bulletproof-sdk-releases) - [Designing How Work Feels: The Science Behind Sanofi’s Workplace Experience](https://www.wearedevelopers.com/videos/1848-designing-how-work-feels-the-science-behind-sanofi-s-workplace-experience) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) - [OTel You It's Not Just for Backend!](https://www.wearedevelopers.com/videos/2001-otel-you-it-s-not-just-for-backend) ## Related Articles - [Best Companies to Work For in Berlin: Top 14 Companies in 2023 ](https://www.wearedevelopers.com/magazine/188-best-companies-to-work-for-in-berlin-top-14-companies-in-2023) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [Where To Find Software Engineering Jobs](https://www.wearedevelopers.com/magazine/396-where-to-find-software-engineering-jobs) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs)