Principal Quality Engineer (Engineering Systems)

Quality Santa Clara, CA

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Description

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.

Description

Position Overview   
The Principal Quality Engineer (Engineering Systems) works closely and partners with internal departments to validate electronic systems, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures.  The Principal Quality Engineer (Engineering Systems) provides Quality Assurance support to functions with a focus on systems compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, and other relevant standards/regulations.  This includes supporting project teams to ensure that electronic systems are designed, developed and validated in accordance with customer, corporate, and regulatory guidelines.
Essential Job Functions
  •  Lead/coordinate/perform validation activities for:
    • New Software Systems, including but not limited to:
      • LMS – ComplianceWire
      • QMS – ETQ
      • PLM – Windchill
      • MES
      • CMMS – eMaintenance
      • ERP – Oracle
      • Document Storage – SharePoint
    • Hardware Systems
  • Support Johnson & Johnson Integration efforts.
  • Develop device Quality Plans to ensure that the elements of the Quality Management System are appropriately described and managed.
  • Initiate, review, and approve Document Change Orders (DCO)
  • Participate in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.)
  • Participate in the implementation and continuous improvement of the Quality Management System.
  • Other duties as assigned.
 
Requirements  
  • Bachelor of Science degree in Engineering.
  • Experience with Software and Hardware Validations.
  • 10+ years of hands-on experience working as an engineer in the Medical Device industry.
  • Working knowledge of applicable medical device regulations such as ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, and MDSAP required.
  • Working knowledge of IEC 62304, IEC 62366 and IEC 60601 is preferred.
  • Ability to perform multiple tasks concurrently with accuracy.
  • Ability to take a hands-on approach and lead cross-functional teams
  • Clear and effective communication skills
  • Must be able to communicate effectively with all levels of the organization in both verbal and written formats
  • Proficiency in MS Word, Excel and Power Point required
  • High attention to detail and accuracy is required
  • Ability to work in a fast-paced environment while managing multiple priorities. 
  • Operate as a team and/or independently while demonstrating flexibility to changing requirements.
  • Employee may be required to lift objects up to 25lbs.

 

Market Range:

$144,000 - $180,000
Exact compensation may vary based on skills, experience, and location.

Benefits
Shockwave Medical offers a competitive total compensation package as well as the following benefits and perks:

Core Benefits: Medical, Dental, Vision, Pre-tax and Roth 401k options with a fully vested match, Short-Term and Long-Term Disability, and Life Insurance, Employer contribution toward Health Savings Account (HSA), Competitive PTO balance

Perks: Calm App, Pet Insurance, Student Loan Refinancing, Spot Bonus awards

EEO Employer

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