Senior Engineer, Device Technical Operations (Hybrid)
About The Position
The Senior Engineer - Device Technical Operations is a key engineering role within the Device Development and Technology Organization, responsible for building engineering capabilities related to medical devices and combination products. The role manages internal and external manufacturing during development, scale-up, commercialization, and design transfer, with a focus on complex drug-delivery systems such as autoinjectors, ophthalmic products, and inhalation products. As a technical subject matter expert on device components, combination products, and processes, the Senior Engineer supports global commercialization and technology transfer activities and drives product robustness for sustained launch in alignment with business goals and quality and regulatory requirements. The position works across development and lifecycle management, supports manufacturing sites and partner groups, and helps ensure activities meet safety, quality, and regulatory standards.
Requirements
- Bachelor’s degree in mechanical engineering, biomedical engineering, or a related technical field is required.
- At least 5 years of experience in pharmaceutical, biologic, medical device, or combination product engineering, including at least 2 years supporting commercial manufacturing.
- Expertise in design controls, risk analysis, control strategies, design verification testing, and process validation.
- Strong understanding of quality management systems and regulatory compliance.
- Demonstrated technical experience in injection molding, automation, and complex assembly and packaging operations for medical device or combination product component manufacturing.
- Required skills include 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, and technology development.
Nice To Haves
- Advanced degree (Master's or PhD).
- Direct experience with autoinjectors, ophthalmic products, or inhalation products.
Responsibilities
- Apply expertise in design controls, design transfer, control strategies, device risk management, and design verification testing to develop solutions for medical devices and combination products.
- Support internal and external component manufacturing and combination product manufacturing globally.
- Identify issues from minimal signals, determine root causes, and provide solutions.
- Build a design engineering mindset for medical devices and combination products across development and lifecycle management while ensuring compliance with relevant regulatory standards.
- Use engineering best practices and tools to optimize design and manufacturing and support robust technical and program decisions across development and commercialization teams.
- Support responses to regulatory agency questions and pre-approval inspections during product development and lifecycle management.
- Develop and execute strategic technology transfer plans, solve problems, lead teams in late stages of development, and collaborate with external and internal partners.
- Foster inclusion by integrating input and perspectives from varied sources to meet customer and stakeholder needs.
- Build strategic partnerships with manufacturing sites and partner groups.
- Ensure activities meet safety, quality, regulatory compliance, divisional, and local site requirements.
- Support regulatory inspections and maintain proficiency in ISO 13485, ISO 14971-2019, and other relevant quality management systems.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and their families.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
