Senior Scientist, Drug/Device Combo Product- Hybrid

Job Description

As a Senior Engineer in Device Design and Process Development group, you will be part of our Research & Development team that designs and develops benchtop/low-volume to high-volume clinical and commercial assembly equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly and process development using semi-automated and automated equipment, conduct functional testing, assist in clinical batch manufacture as an equipment subject matter expert, assist with acceptance testing (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:

• Experience with, and a fundamental understanding of medical device assembly equipment to enable development of product specific processes and controls with a focus on DFM/DFA principles.

• Understanding of autoinjector/parenteral/pre-filled syringe delivery device design and function, and the ability to develop robust assembly specifications with sound justification.

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

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

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

• Author technical content of assembly process FMEAs to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient throughput.

• 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.

• 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 acceptance testing (FAT) and report project progress, risks, and mitigations to the team.

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

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

Education qualifications:

• A bachelor’s or master’s degree in mechanical engineering with 5 years of relevant work experience.

Required Experience:

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

• Strong problem-solving and technical writing skills.

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

Preferred Experience:

• 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.

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

• Experience in machining, prototyping and 3D printing.

• Rudimentary understanding of automation controls and wiring diagrams.

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