Principal Engineer, Process Dev, R&D

Position Summary

Collaborate with Design Development, Product Development, and Manufacturing Engineers to define the design and processes for new products that meet the clinical needs.

Principal Responsibilities

•    Lead a small team of engineers to define and effectively execute the process development strategy. 
•    Represent the process development function on the core team through collaboration, strategy, technical knowledge, and communication.
•    Manage the planning, execution, and documentation of all process development & validation activities for new products based on, projected product volume, project timelines, and COGS targets.
•    Actively pursue design, process, and equipment improvements to improve process reliability and minimize product manufacturing cost.
•    Make process decisions that minimize process issues and resolve those that occur.
•    Specify, design, characterize, optimize, and implement manufacturing processes that are capable of meeting design, quality, productivity, and cost requirements.
•    Investigate and troubleshoot process issues, determine causes, and implement solutions.
•    Develop and implement easy to follow work instructions to produce products that meet requirements.
•    Establish project timelines, track progress, manage to the schedule, and communicate project status to management and project leader.
•    Lead generation of product development process documentation (e.g., PFMEAs, characterization studies, protocols, reports, MPs, Design Transfer reports, etc.).
•    Plan, coordinate, and execute process validations.  Transfer validated processes and equipment into production for commercial manufacturing.
•    Coordinate with production to produce initial finished goods inventory for new product launches.
•    Perform test data analysis. 
•    Conduct risk analysis, failure analysis, and root cause investigations and report the results.
•    Coordinate and execute product development builds.
•    Build partnerships and collaborate with others to meet shared objectives.
•    Work effectively in a diverse group, respect different ideas, perspectives, and values.

Education / Experience Requirements

•    BA/BS in Engineering or physical sciences required.
•    8 years of related experience required.
•    Expert-level experience working in medical device catheter process development.
•    Expertise in process validation (IQ, OQ & PQ), experience with various production processing methods and the product/process development cycle 

Specialized Skills / Other Requirements

•    MS in Engineering or physical sciences preferred.
•    Experience successfully leading a process development team through a catheter development project from concept to commercialization.
•    Expert level experience with many of the processes and process aids used in catheter manufacture; polymer laser bonding, hot die polymer bonding, UV adhesive bonding, injection over-molding, catheter reflow, marker band swaging, metal laser bonding, roll-cut, pressure testing, tipping, heat shrink, mandrels, balloon pleat and fold, laser micrometer, optical micrometer, balloon forming, nitinol forming, nitinol laser cutting, braid reinforcement, coil reinforcement, induction heating, hydrophilic coating, silicone coating, packaging, PTFE liner stretch, assembly, metrology, inspection, and fixtures.         
•    Knowledge of the first principles behind catheter processing.
•    Knowledge of poka-yoke tools and implementation.
•    Recognized as having a knack for independent problem solving of mechanical and/or electrical systems.
•    Persistent in achieving success using a productive and positive approach.
•    Experience using Minitab to perform data analysis (including DOE, ANOVA, hypothesis testing, gauge R&R, capability analysis, normality analysis, distribution identification, graphing, etc.) 
•    Demonstrated project management skills and ability to coordinate multiple projects simultaneously.   

TRAVEL REQUIRED: up to 25%

The pay range for this position at commencement of employment is expected to be between $144,600- $216,900 however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
 
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.