
Principal R&D Engineer (Sustaining) - Shockwave
- Santa Clara, CA
- Permanent
- Full-time
- Provide technical leadership for projects in coronary and peripheral artery space.
- Provide mentorship to other engineers and assignments to technicians as required.
- Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies for manufacturing processes.
- Supports pilot manufacturing as well as commercial production
- Support commercial products as subject matter expert on product design, including design changes and regulatory inquiries.
- Prototype and develop proof of concept designs and test methods based on the defined user needs and requirements.
- Represent R&D in cross-functional teams that drive geographical expansion of products.
- Solve challenging and complex technical problems during the new product development process and in support of commercial products.
- Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation.
- Develop protocols/reports and perform product assessment as well as verification and validation testing.
- Perform process-related design tasks to support pilot manufacturing, utilizing Design for Manufacturing principles and working with assemblers to ensure robust processes.
- Identify suppliers and maintain relationships to ensure the delivery of superior components and services.
- Enhance the intellectual property position of the company via invention disclosures and patent applications.
- Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization.
- Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements.
- Ensure proper documentation consistent with company’s quality system.
- Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives.
- Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products.
- Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations.
- Other duties as assigned.
- Bachelor’s Degree in Mechanical or Biomedical Engineering and 10 years’ experience in engineering OR a Master’s Degree and 8 years’ experience in engineering.
- Experience in early-stage catheter and/or lead based cardiovascular device development.
- Knowledge of disposable structural heart device design, material selection, and testing is a strong plus.
- Strong understanding of engineering materials, component selection, and design for reliability and manufacturability.
- Strong understanding of statistics including design of experiments, Gage R&R, capability, etc. is a strong plus.
- Strong teamwork skills and demonstrated ability to work closely with cross functional partners.
- Effective communication skills with all levels of management and organizations.
- Operate independently and adaptability to changing requirements.
- Ability to work in a fast-paced environment, managing multiple priorities.
- Employee may be required to lift objects up to 25 lbs.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Additional information can be found through the link below.