Sr. Process Development Engineer
This Senior Process Development Engineer will support the development of multiple next generation products and projects.
This position requires a strong technical background and mechanical aptitude to support the development of innovative medical devices. The Senior Process Development Engineer will report to an Process Development Manager that will provide guidance and limited supervision. This level position requires an extensive knowledge base and a high degree of independence. The role will support project teams with tasks and responsibilities distributed across all phases of research and product development, from concept through commercialization, including products, materials, processes and equipment.
Majority of the Senior Process Development Engineer’s time will be spent in the R&D lab or on the production floor typically tasked with; troubleshooting issues, building prototypes, testing devices, collecting data, developing processes, building fixtures, performing equipment set-up, and updating documentation. This role will work closely with R&D project teams and will have an excellent understanding of associated processes and equipment.
- Bachelor’s degree in Engineering
- 3+ years of applicable Process Development/Manufacturing Engineering experience
- Experience within medical technology industry for a minimum of 2 years.
- Experience with catheter manufacturing
- Multilayer catheter constructions
- Vertical Reflow processes
- Plastic welding and shaping
- Experience with Nitinol MFG (shaping/forming, coating) is a plus
- Knowledgeable and experienced in medical device construction techniques such as swaging. soldering, brazing, welding and other catheter, guidewire, and sheath construction techniques.
- Strong mechanical aptitude including experience with the assembly of new medical device concepts and knowledge of manufacturing techniques applicable to the art.
- Familiar with design controls process
- Ability to setup and perform equipment validations
- Ability to setup/perform/analyze Process Validations
- Manufacturing knowledge to identify the need for new equipment and fixturing to aid in the manufacturing process
- Knowledge of manufacturing principles (i.e., Lean, 6-Sigma, Just-in-Time)
- Ability to document process steps and create work instructions.
- Demonstrated ability for creative thinking and problem-solving skills
- Capable of understanding/following/creating instructions and standard operating procedures, protocols, etc.
- Ability to read and create engineering drawings, as well as, diagrams, charts/graphs, and schematics.
- Solid Interpersonal abilities for effective communication in a team oriented environment
- Understanding of FDA, QRS(GMP)/MDD and ISO standards, with the ability to learn through exposure to additional industry standards.
- Hands on, motivated attitude. Takes initiative and able to complete tasks with minimal assistance.
- Strong communication skills with the ability to communicate ideas to engineers, technicians, and production staff
- Participate in developing next generation products for the treatment of peripheral and coronary artery disease
- Responsible for planning, organizing and managing engineering projects
- Plan and manage projects from initiation to closure
- Ability to find and evaluate new processes, equipment, and suppliers
- Ability to work in office, lab, and production environments
- Interface with Research & Development for design for manufacturability
- Determine, document, and train on manufacturing best practices
- Validate processes and equipment for FDA compliance
- Ensure manufacturing equipment and methods are safe and efficient for operators use
- Reduce cost and lead time by standardizing and streamlining production processes through quality improvements, fixturing, and automation
- Perform additional duties as assigned with little direction from manager
- Work cooperatively with Quality, Regulatory, Manufacturing, Sales and Marketing
- Perform experiments and feasibility tests on a variety of designs
- Assist in the generation of documentation (e.g. datasheets, technical reports, PowerPoint presentations)
- Coordinate and execute bench and preclinical studies
- Build and test early stage prototype devices
- Troubleshoot and suggest creative solutions to process and design issues
- Analyze data using basic statistics
- Ability to work independently, manage time effectively, and prioritize projects based on timing and importance
- Work collaboratively in a team oriented, fast paced environment
- Fabricating prototypes and building test samples and equipment
- Collect and compile data for technical reports.
- Demonstrate an ability to learn new technologies and processes in a timely manner.
- Demonstrate strong attention to detail to prevent and minimize defects in data.
- Work with vendors to procure supplies and general oversight of contractors (general interaction with technical resources).
- Able to communicate both verbal and written information to management.
- Perform troubleshooting of process or testing problems and suggest alternatives.
- Document development activities through lab notebook and other appropriate records.
- Prioritize and complete research in a timely, reproducible manner independently and within teams.
- Prepares summary laboratory reports of research or development activities which present findings and conclusions.
- Able to scientifically discriminate, analyze and offer conclusions to difficult laboratory problems.
- Performs other work-related duties as assigned and carries out duties with minimal instruction.
Administration/ Working Conditions:
- Basic computer skills including Microsoft Word, Excel, Powerpoint and SolidWorks.
- Assembling small parts under microscope for extended periods of time.
- Overtime hours as required, but limited.
CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.