Senior Engineer, Drug-Device Combination Products

Job Description

This position is in our organizations Device Development & Technology (DD&T) group in our Research division. Our organizations 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 companys goals/objectives. The group also plays a key role in supporting commercially launched products.

Our companys 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 companys 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 addition this position shall interrogate device supplier processes as they relate to our companys combination product process specifications and critical quality attributes to support our companys 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.

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• 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 skillswith an ability to collaborate in a team environment

• High level work ethic

• Support process and technology transfer to our companys 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:

Preferred Skills:

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

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