Provides supervision and technical leadership to process development engineering employees who are responsible for planning, developing, and coordinating new therapeutic device development projects. The Process Development manager works cross-functionally to ensure that the therapeutic device development program priorities are determined and met, logistics are effectively coordinated, and budgets are adhered to.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Create and implement manufacturing processes for Bolt's new and current catheter devices.
Identify new catheter medical device equipment and processes to optimize process throughput and process reliability.
Perform characterization, Design of Experiments (DoE), and write/perform validation/verification of processes/inspection methods for manufacturing (IQ, OQ, PQ).
Create manufacturing documentation, including work instructions, forms, BOMs, routers, FMEAs, DMR, and DHF documents.
Lead a team of engineers and technicians on business activities for the process development team.
Innovate, design, and develop processes, procedures, tooling, and/or automation.
Manage machine shop engineers/technicians.
Train and provide direction to direct reports and manufacturing personnel.
Drive functional excellence initiatives for product/process and technical development.
Develop department budget, schedules/forecast, and resources.
Manage production builds for development projects and optimization to meet business needs.
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
Bachelor's Degree in Engineering, preferably mechanical or biomedical.
Experience in Design for Manufacturing (DFM), Lean Manufacturing, Design of Experiments (DoE), technology/process transfer, product/process failure mode and effects analysis (FMEA), and problem-solving methodologies.
Understanding of medical device design controls/quality systems and product development processes.
12+ years of medical device experience in a process/manufacturing engineering role.
Minimum of 8 year's experience working in catheter manufacturing environment.
KNOWLEDGE, SKILLS AND ABILITIES:
Background in fiber optics, adhesive bonding, EDM, thermal bonding, laser bonding, mechanical assemblies, machining, injection molding, extrusion and electrical assemblies is preferred.
Solid knowledge of FDA regulations and interpretation of FDA regulations, guidelines, and policy statements.
Excellent verbal and written communication skills.
Ability to organize, record, and implement procedures.
Individual must have experience with CAD (Solid Works) to create and design fixtures and equipment.
Understanding of six sigma principles (certificate desired) and statistical software such as Minitab