Principal Engineer, Delivery System Process Development

Job Title: Principal Engineer, DS Process Development

• Principal Engineer I, DS Process Development
• Principal Engineer II, DS Process Development
• Principal Engineer III, DS Process Development

Supervisor/Manager Title: Manager, DS Manufacturing

Job Description Summary: Responsible for Process Development and manufacturing engineering activities. Act as an interface between R&D, pilot, and commercial manufacturing. Contributes to the Delivery System product life cycle. Optimization and development of new or current manufacturing processes.

Job Responsibilities:

• Technical engineering support for Delivery Systems to ensure process and equipment are characterized and scaled by utilizing new technology and standard work.
• Lead/support equipment, tooling, and fixture design for development and production activities.
• Identify and implement manufacturing process improvements internally and at contract manufacturers.
• Analyze and resolve complex manufacturing and compliance issues (CAPA, non-conformances, audit observations, etc.).
• Lead short-term and long-term manufacturing process improvement activities.
• Partner with Quality and R&D Engineers to develop and implement critical manufacturing processes.
• Process development of manufacturing processes and validations (IQ/OQ/PQ) for new product introduction and continuous improvement.
• Provide root cause analysis investigations and development/implement corrective actions for component and device nonconformance.
• Managing key suppliers and working directly with contract manufacturers.
• Provide technical support for design qualifications, design transfer, activities for regulatory submissions, product and Process Development and implementation of design control documents, and approval of product/process change.
• Manage all manufacturing-related aspects of the project within a team.
• Develop training and documentation materials (e.g., work instructions) for development and production activities.
• Provide real time production line support.

Required Education and Experience:

• A Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree) is required.
• Minimum of 12+ years’ experience in Manufacturing or R&D Engineering is required with a preference in Delivery Systems or catheters. Level I, II, III DOE.
• Must have experience in the use of CAD (SolidWorks) packages.
• Knowledge of equipment qualification (IQ/OQ/PQ) and design verification (including statistical techniques used) in the medical device industry or other regulated industries is required.
• Must have experience in designing and implementing fixturing from design concept to a clinical/commercial production line.
• Must have experience in implementing equipment from parameter/settings origin to the production line.
• Knowledge and experience in Work Instruction creation and implementation.

Skills and Abilities Required for This Job:

• Must have experience in the use of CAD (SolidWorks) packages.
• Must be able to work effectively and collaborate within cross-functional teams.
• Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
• Must have strong project management and documentation skills.
• Must take initiative and have the ability to conduct hands-on work.
• Must possess the ability to handle multiple tasks with high attention to detail.