Company Type
Medical Device
Location
Palo Alto, California
Job Description
- Design and develop new medical products to meet customer requirements within scope (e.g., performance and quality), schedule (e.g., on time delivery), and budget (e.g., price) constraints.
- Polymer science and extrusion experience.
- Develops design solutions to complex technical problems where analysis of data requires an in-depth evaluation of many factors. Solutions require use of ingenuity and creativity.
- Performs work under general supervision on multiple NPI projects. Exercises considerable latitude in determining technical objectives of assignment. Provides leadership, periodic consulting, and training for less experienced team members.
- Lead initial technical reviews and cost estimation analysis of new products to support quote generation.
- Translate customer’s product requirements into achievable product specifications and design features.
- Lead FMEA (Failure Mode Effects Analysis) and risk analysis reviews on NPI (New Product Introduction) products.
- Lead a series of cross-functional design reviews throughout the NPI process.
- Document product development progress conforming to operating procedures of the Product Lifecycle Management (PLM) phase-gate system.
- Direct proof-of-concept and design verification testing and write final test reports for communication with internal and external customers.
- Ensure new designs meet relevant environmental and regulatory Design History File (DHF) requirements.
Job Skills
- Demonstrated leadership and drive – these two items are a top priority.
- Medical device experience of at least five years.
- Extensive experience in qualifying and developing the following processes – Extrusion, Beaming, Expansion of tubing.
- Demonstrated exceptional leadership skills in driving projects to completion.
- Demonstrate ability to provide work directions and manage techs and development lab.
- Excellent oral and writing skills.
- Can deal effectively with senior leadership, colleagues and technical staff.
- Innovator and demonstrated excellence in execution.
- B.S. in Engineering (Mechanical or Plastics preferred); M.S. or Ph.D. in Engineering a plus.
- Five or more years of related extrusion/expansion product design and development engineering experience with a B.S. degree or two or more years with a M.S. degree.
- Medical product development experience and knowledge of FDA regulations preferred.
- Can-do attitude, resourceful, action oriented, and drive for results.
- Demonstrated technical contribution through creative product design solutions that have been successfully launched into the market.
- Demonstrated inventiveness through invention disclosures, patents, active participation in professional organizations, technical conference presentations, etc.
- Advanced knowledge of materials and resins, manufacturing processes (e.g., plastic injection molding, extrusion, expansion, and compounding), sterilization, catheter assembly, braiding, and advanced statistical techniques.
- Demonstrated aptitude of innovative mechanical and process development skills including but not limited to frequent use of 2D and 3D CAD (Pro/Engineer) modeling, GD&T, and prototype creation.
Job ID: 3400
