Sr. Engineer, Device Technology (Hybrid)

Job Description

Job Summary:  

Sr. Engineer, Device Technology 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 scale-up, development, commercialization, and design transfer of medical devices and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The Sr. Engineer role is a technical subject matter expert on the device components and combination products 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, device transfer, control strategies, device risk management, and design verification testing to develop value-added solutions for medical devices and combination products.

• Provide support for the internal and external component manufacturing, combination product manufacturing, globally

• Identifying 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 a 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 Engineer, or a related a technical field (e.g., Chemical Engineering, Materials Engineering) required; advanced degree (Master's or PhD) preferred.

• Minimum of 4 years of experience in pharmaceutical, biologic, medical device or combination product engineering, with at least 2 years in managing external partners and suppliers.

• 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, with experience in autoinjectors, prefilled syringes, and complex drug delivery systems.

#eligibleforERP

Current Employees apply HERE

Current 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