Summary:Silk Road Medical is an innovative, rapidly growing company which has developed a less invasive, catheter-based approach to treat carotid disease: TCAR (TransCarotid Artery Revascularization). We are seeking a mechanical design engineer to lead efforts in the design of new products and to provide sustaining engineering support for existing product lines. This individual will work closely with cross-functional team members, external resources and physician advisors to understand design requirements and to successfully execute project goals to meet customer needs.
Essential Duties and Responsibilities: (Other duties may be assigned)
- Work with Marketing, Clinical, CMO and physician advisors to understand and codify customer requirements. Develop deep understanding of procedural needs and constraints to inform this understanding.
- Design, prototype and develop novel concepts to improve performance and ease of use for currently available products
- Develop test methods and perform robust design evaluation to ensure that product designs meet customer needs. This shall include bench testing, model development, ex vivo and/or in vivo testing as appropriate
- Maintain Design Control activities for product development projects: developing product specifications, collecting design input via input from advisors and initial design evaluation, managing risk analyses, meeting goals for design reviews, and establishing and leading design verification and validation strategies.
- Lead design update activities to improve performance, safety, compliance and/or cost of current commercially available products. Activities to include: updates to design, materials or processes; development and implementation of new and improved test methods.
- Support Company functions as needed, including R&D, Operations, Quality, Clinical and Regulatory.
- Support the development and upkeep of the Company’s quality system in conjunction with the Company’s Quality Department
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- BS or greater in Engineering, or equivalent industry experience
- Minimum of 6 years of experience in industry, 4 of which are in medical device R&D.
- Excellent design and hands-on prototyping skills.
- Extensive product and process development experience.
- Strong interpersonal communication skills for interaction with cross-functional team members, physician advisors and external resources.
- Proficient in CAD design, analysis and documentation software.
- Project management experience and strong report writing, drafting and documentation skills.
- Experience working with FDA and ISO Quality System Requirements.
Interested candidates should submit their resume to email@example.com. Please list the region and position you are applying for in the subject line of the email.