Senior Engineer, Device Automation and Process Development (Hybrid)

Job Description

As a Senior Engineer in Device Design and Process Development group, you will be part of our R&D team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for drug delivery systems. Reporting to the Director responsible for this area, you will partake in device assembly and process development using semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as equipment SME, assist with FAT, SAT, installation/qualification of equipment at our manufacturing sites, interrogation of subassembly processes at our device supplier sites, and provide hands-on troubleshooting to operations as needed.

Key Responsibilities:

• Understand product design, functionality, storage, and handling requirements to develop robust equipment and processes for clinical and commercial manufacture of drug-device combination products.

• Understanding of parenteral delivery device design and function, and the ability to develop robust assembly specifications with sound justification.

• Gain fundamental understanding of existing assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.

• Familiarity with assembly equipment integrated processes such as ultrasonic welding and vision inspection systems.

• Develop characterization plans and prototype small-scale equipment to prove out concepts prior to implementation.

• Conduct testing using tensile tester or other laboratory equipment and analyze data to inform process development activities.

• Assist clinical manufacturing team with authoring relevant SOPs and specifications to enable clinical batch manufacture.

• Hands on troubleshooting in a manufacturing environment with an ability to operate assembly equipment and/or assist clinical manufacturing team with batch manufacturing.

• Interface with key stakeholders within the design team, molding team, design verification team, device technical operations, and manufacturing sites.

• Travel to OEMs to review equipment design, conduct line trials including FAT and report project progress, risks, and mitigations to the team.

• Author process FMEA to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient throughput.

• Author protocols, reports, create drawings and specifications to ensure proper documentation of process development activities in accordance with relevant SOPs.

• Identify and implement process improvements by working collaboratively with device technical operations and manufacturing sites on existing and new equipment.

Education qualifications:

• A Bachelors or Masters degree in Mechanical Engineering with 5 years of work experience

Required:

• Experience in the design and development of assembly equipment and processes.

• Strong problem-solving and technical writing skills.

• Proficient in computer-aided design (CAD) and computer-aided engineering (CAE) software such as SolidWorks, AutoCAD etc

• Excellent collaborative and communication skills, with a proven ability to work effectively with cross-functional teams and external partners to achieve strategic business goals.

• Working knowledge of regulatory requirements and standards (21 CFR Part 4, 21 CFR Part 820, ISO 13485, ISO 14971 etc.)  and industry standards related to medical device manufacturing is a plus.

• Prior experience in glass container handling/assembly and complex medical device manufacturing (molding and assembly) is preferred but not required.

Preferred:

• Experience in machining, prototyping and 3D printing

• Rudimentary understanding of automation controls and wiring diagrams

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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