Sr Product Development Engineer - Catheters

Overview

Job Summary Activities include product design and development, defining technical solutions to abstract problems, defining methods and processes, design modeling, tooling design/fabrication, equipment design/fabrication, personnel management, design verification and validation, and documentation. Manage the day-to-day execution of reliability tasks by teams and team members through monitoring progress, providing technical direction, and problem-solving solutions. Design and develop innovative products, incorporating Design for Manufacturability and Assembly principles, managing the product design from concept to full production.

This position will lead in the execution of development projects as part of a multi-functional project team.

• Research, design and implement new products based on customer specifications
• Develop product requirement specifications based on customer needs and applicable guidelines (industrial and government guidelines and/or standards)
• Understand the end use of products, determine fitness-for-use of materials, and effectively advancing the specification development of new and derivative products
• Specify and develop tests for product testing determining acceptability of designs to requirements
• Perform data analysis (statistical and practical) and develop appropriate action plans based upon such analysis
• Develop tooling and test equipment designs for product assembly and testing
• Prepare and present plans and schedules as Technical Project Lead
• Serve as Technical leader, and cross-functional team member representing Product Development, for development projects (as assigned).
  
  Duties include:
  
  task management, organize and facilitate technical team meetings, lead technical reviews, provide documentation and coordinate project activities
• Perform as a technical resource to all departments with a thorough understanding of related disciplines
• Contribute to the development of project plans that meet the required customer and/or internal milestones, specifications, and product cost goals, within project budget and staff assignments
• Communicate progress and decisions to customers, associates and functional managers
• Assist management in improving systems for product development, standard operating procedures, safety, quality control and training
• Identify opportunities for productivity and quality improvements
• Perform product/process analysis for cost reduction, quality improvement, and improved efficiency
• Perform research, design and development of product assembly methods including production equipment
• Create breakthrough strategies that alter the competitive dynamics in a market and establishes a series of competitive advantages yielding profitability that exceeds expectations for the organization
• Perform formal root cause analysis
• Provide risk based decision making using formal risk management tools
• Support company finance, accounting, human resources, quality, regulatory, and clinical departments as necessary to ensure compliance with requirements
• Follow company policies and procedures

Functional Knowledge

• Good engineering techniques
• Knowledge of human anatomy
• Able to effectively communicate about very technical subjects with peers and customers
• Knowledge of machining and assembly practices, tools and fixturing is required. Knowledge of plastic and/or metal is preferred

Education, Experience, Required Skills

• Bachelor’s degree in related field (equivalent work experience may be considered)
• Catheter shaft design and development experience, preferably in the cardiovascular market required
• 5+ years of medical device industry experience as an individual contributor, with at least 4 years in catheter shaft design and development.
• Strong strategic focus in the areas of Product and Process Development is ideal but not required
• Ability to handle and be trusted with confidential and/or sensitive information
• Strong problem-solving skills to identify, gather, and analyze information develop solutions and resolve problems in a timely manner
• Must have knowledge of machining and assembly practices, tools and fixturing (plastic and/or metal preferred)
• Experience in contract design or manufacturing (preferred but not required)
• Proficiency in 3D CAD Software (preferably Solid Works) In addition to fixture design, must be able to open, view and manipulate assemblies
• Demonstrated ability to implement change, in a way that positively impacts overall department and company performance
• Must be able to handle multiple projects simultaneously
• Must excel at working in a team environment with a high level of people/interpersonal skills and demonstrated ability to cross functionally drive results
• Excellent written and verbal communication skills, emotional regulation? Is there a way to talk about this as a soft skill?
• Able to work in a fast-paced, constantly changing environment
• Ability to be flexible and to handle multiple projects in an organized, timely manner
• Able to problem-solve, work under pressure, and to effectively…