Job Summary:

The Senior Product Development Engineer performs product design activities to ensure product development completion from concept to commercialization.  This position requires a strong technical background and mechanical aptitude to support the development of innovative medical devices.  This individual is expected to lead or work collaboratively with a team of engineers to develop product solutions to meet strategic goals. This individual will bridge gaps between technical and non-technical individuals to support CSI’s design control process.  Additionally, this individual will integrate with mechanical, electrical, software, and design assurance engineers to ensure deliverables and receivables are meeting the needs of each group. 

Essential Duties and Responsibilities:

• Designs catheter-based technologies.
• Leads product development projects by managing design control process.
• Excels in a high energy, fluid environment, with multiple responsibilities.
• Defines and translates customer needs into technical requirements, engaging the customer, sales, marketing, and other functions as needed.
• Defines and analyzes system requirements, clinical workflows, and input/output processes by using current systems engineering methods and technologies.
• Initiates and reviews product testing in support of product design, regulatory submissions, manufacturing, quality, and sales support.
• Develops technical documents and presentations to communicate results to a technical team.
• Initiates, performs, and reviews animal or cadaveric product testing in support of product design and sales support.
• Works as a "hands-on" engineer in performing troubleshooting on new products/process problems as related to design, material, or process.
• Demonstrates knowledge of technical and product development processes through delivery of high quality and high impact deliverables.
• Provides technical expertise for manufacturing, quality, marketing and sales, as directed.
• Travels, as required, for professional meetings or in association with product development or technical activities, which includes interfacing with physicians to obtain feedback on concepts and performance of new devices.
• Works with the in-house legal department, outside legal consultants, and government patent officials, as required, on patent searches, patent infringements, and patent applications and acts as technical expert on all design related materials and provides strategic analysis for continued direction.
• Consistently generates innovative and unique solutions to market needs and submits idea disclosures resulting in the development of new or refined products, processes, or equipment.
• Provide technical mentoring of junior level engineers in the areas of product design, testing, and performance
• Timely and effectively communicates status, issues, and budgetary information to management.

Knowledge, Skills and Abilities Required for Successful Job Performance:

• Minimum Qualifications
  • Bachelors or Master’s Degree in Mechanical, Biomedical, Systems, or similar engineering discipline
  • Experience in leading all technical aspects of the product development process.
  • Minimum of 5 years of relevant experience in product development of medical devices preferred.
• Knowledge, Skills and Abilities Required for Successful Job Performance:
  • Ability to provide technical oversight to the technical team, lead completion of design control documentation, and support completion of the project deliverables.
  • Strong analytical and problem solving skills. Ability to solve complex problems and implement solutions or processes. Ability to solve systems-level problems by understanding the how changes impact the overall system.
  • Strong communications skills to understand and explain complex engineering problems to non-engineering personnel. Ability to create and deliver presentations to executive management. Ability to create detailed technical reports appropriate to send to regulatory bodies (FDA, etc).
  • Strong coordination skills to align cross-functional team members to deliver results and ensure a quality product that meets customer needs.
  • Strong decision making skills. Ability to perform comparative analysis on alternate product designs, component sources, process methods, or test methods and make design recommendations.
  • Ability to appropriately create documentation to be contained in DHFs or regulatory filings.
  • Ability to define, write, and perform test protocols including design verification for evaluating product performance to confirm specification is achieved.
  • Ability to travel to observe clinical cases, attend trade shows, attend training activities, and visit suppliers, etc. will be required periodically. Vendor credentialing for hospitals is required.
  • Experience with creating, reviewing, and approving technical drawings.
  • 3D CAD software experience required with SolidWorks experience preferred.  Must be at a professional proficiency level in SolidWorks or ProE; SolidWorks is to be used for all documented design work.
  • Materials experience in polymers, metals, and micro scale components.
  • Experience with researching and applying regulatory and international standards. 
  • Knowledge of practical mechanical design, materials, manufacturing methods with the ability to apply appropriate methods and techniques
  • Ability to multi-task in a fast-paced environment.
  • Expertise in one or more product development disciplines (e.g., machining/injection, molding/extrusions, etc.).
  • Experience performing usability and risk analysis (dFMEA, etc).
  • Experience analyzing test results and performing statistical analysis (Minitab, JMP, etc).