Sr. Quality Engineer

at  Shockwave Medical

Shockwave Medical, Inc. is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

POSITION OVERVIEW:

The Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports.

REQUIREMENTS:

• BS in a related engineering discipline and 5+ years of related experience; or MS in a related engineering discipline and 3+ years of related experience
• Experience in the medical device industry is highly preferred
• Strong technical writing skills are required
• Experience in customer complaint investigations and complaint report writing
• Experience in manufacturing support as a Quality Engineer
• Must be proactive, self-motivated, and work independently with minimal supervision
• Experience with balloon catheters and electrical systems is strongly preferred
• Experience in completing Medical Device Reports (MDR) and Vigilance (MDV) submissions is an asset
• Experience in writing and reviewing design verification and validation protocols
• Preferred experience in generating documentation and criteria for validation of manufacturing line transfer to alternative sites
• Certified Quality Engineer would be an asset
• Must be willing to travel up to 10% of the time
• 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
  Market Range: $113,000 - $135,000
  Exact compensation may vary based on skills, experience, and location.

Please refer the Job description for details