Senior Engineer, Drug-Device Combination Products

Medical Device Product Manufacturing And Assembly Engineer

This position is in our organization's Device Development & Technology (DD&T) group in our Research division. Our organization's DD&T group is responsible for the development of devices, combination products, processes, testing and assembly equipment from conception through product launch. Products include autoinjectors, inhalers, implants, infusion pumps, vaginal rings and connected devices/apps. The person in this position contributes to high impact, complex, cross-functional, and cross-divisional teams, initiatives and will provide input to achieve project goals.

Effective collaboration with teams is essential to meet our company's goals/objectives. The group also plays a key role in supporting commercially launched products.

Our company's DD&T Team is seeking a hands-on medical device product manufacturing and assembly engineer. This position will be responsible for hands-on factory floor work and collaboration, via interfacing with our company's internal sites, medical device suppliers and sub-suppliers. This includes working with both small to large scale medical device assembly equipment suppliers, integrated manufacturing equipment component suppliers and purchased device component suppliers.

In addition, this position shall interrogate device supplier processes as they relate to our company's combination product process specifications and critical quality attributes to support our company's combination product quality control strategy and preserve essential performance requirements.

Education Minimum Requirement:

• B.S. Degree in Mechanical Engineering or related field with a minimum 8 years of regulated industry experience

Required skills and key responsibilities for this position include:

• Experience in developing, implementing and troubleshooting combination product assembly equipment processes including vision systems, ultrasonic welding and automated component and glass feeding and handling systems
• Author design/process FMEA to capture design related risks and identify appropriate risk controls to ensure robust and efficient device functionality.
• Design and author Process validation activity and documentation like IQ, OQ, PPQ etc.
• Author protocols, reports, create drawings and specifications to ensure proper documentation of development activities in accordance with relevant SOPs.
• Understanding of device and combination product DFM/DFA principles and design and failure modes in relation to assembly processes
• Excellent oral and written communication skills and the ability to present complex information in a clear and concise manner to partner group stakeholders
• Mechanical aptitude and hands-on troubleshooting skills, with the ability to work independently in a laboratory setting and manufacturing floor setting.
• Strong interpersonal skills with an ability to collaborate in a team environment
• High level work ethic
• Support process and technology transfer to our company's manufacturing facilities

Preferred

Experience and Skills:

• CAD design, including knowledge of SOLIDWORKS and
• 3D printing and the ability to prototype and fabricate custom fixtures for assembly and testing

Required Skills:

Analytical Method Development, CAD Modeling, Combination Products, Creativity, Device Development, External Partners, Geometric Dimensioning And Tolerancing (GD&T), ISO 13485 Medical Devices, Manufacturing Processes, Mechanical Design, Mechanical Testing, Medical Device Manufacturing, Method Validation, Product Development, Proper Documentation, Prototyping, Risk Control Assessment, Statistical Analysis, Systems Troubleshooting, Team-Building, Teamwork, Technical Writing, Technology Transfer, Ultrasonic Welding

Preferred

Skills:

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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.

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