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Sr. Quality Engineer - Design Assurance Job

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Date: Jun 2, 2019

Location: San Jose, CA, US, 95101

Company: Boston Scientific

Primary Location: [[filter2]]
Additional Locations: US-CA-San Jose; US-MN-Maple Grove
Requisition ID: 442849

 

 

About this role:

Interface with R&D on development of medical electrical equipment (iLab Polaris Intravascular Ultrasound System) with specific focus on mechanical and electrical elements including development of risk analysis and planning, test plans/reports, and implementation of design processes with compliance to company procedures. Represent DA for Hardware development and sustaining within the PCI Guidance business and engaged with global programs to drive improvements for design procedures specifically targeting hardware and equipment.

 

Provides focused quality engineering support on new product development design assurance.

Design assurance drives the ISO14971 risk management process and the Verification & Validation (V&V) process.   This includes quality plans, risk management plans and reports, hazard analysis, product risk management workbook (user FMEA and design FMEA), sampling systems / procedures and statistical techniques, verification protocols/testing/reports, validation protocols/testing/reports, and reviews marketing and product specifications.  Reviews and approves most documents including marketing specification, product specifications, preclinical work, etc.  Interfaces with all other quality and engineering components within the company and with customers and suppliers on quality related issues.

Job may also support the development of procedures for the quality assurance process for new product development.  Job may support development of quality engineering methodologies, systems, and practices which meet BSC, customer, and regulatory requirements. May conduct training on quality assurance concepts and tools.

Serves as a quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities.

 

Your Responsibilities:

  • Leads or participates in the implementation of new product design (NPD) design assurance: Risk management (per ISO 14971), User and Design FMEAs, requirements traceability matrices, design verification and validation, Design Change Analysis Forms, etc. Utilize statistical analysis techniques to determine product acceptance.
  • Leads or participates in core team meetings, CCB, and MRB meetings.  Interfaces and manages work with other quality organizations such as biocompatibility, microbiology, sterility, and manufacturing/ops requirements.  Thorough understanding of design controls.
  • Participates in design reviews, design transfers, and in all aspects of the Design Control process for the PCI Guidance products. Ensure customer requirements are met by incorporating engineering principals in robust design and in design for manufacturability. Actively participate in all aspects of Design Control
  • Design, develop, refine, and validate test methods and inspection procedures.  Guide/author design verification and design validation protocols and reports.
  • Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).
  • Identifies and implements effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.
  • Lead and participate in product failure investigations and root cause analysis.
  • Provide technical guidance and training to team members in statistical analysis techniques, experimental design and other QA Engineering areas of expertise.
  • Provide technical guidance and training to other department members and engineering staff in statistical analysis techniques, experimental design, data analysis, and product/process verification and validation.
  • Directly interface with people performing internal and external audits.
  • Interface with agents of regulatory bodies as necessary to demonstrate quality system compliance. Support certification / recertification activities for US, European and other markets.
  • Consult with and provide guidance to Quality Technicians and other Quality Engineers.  Work to ensure compliance with corporate quality systems requirements.
  • Provides leadership role on championing departmental or cross-functional engineering initiatives.
  • Provides project direction, coaching, and mentoring for engineering and technical team personnel.
  • Proactively investigates, identifies, and implements best-in-class Quality Engineering practices.
  • Understanding of technologies incorporated into design.

 

Basic Qualifications:

  • 5-8 Years of related experience with Bachelor’s Engineering degree, 3-6 Years with Master’s Engineering
  • Understanding of electrical safety standards IEC 60601
  • Experience with reliability testing
  • Understanding of configuration management
  • Demonstrated used of Quality tools/methodologies
  • Strong written/verbal communication skills.

 

Preferred Qualifications

  • Previous R&D experience
  • Strong knowledge of QSR and ISO standards
  • BS in Electrical Engineering preferred
  • 1-3 years medical device experience
  • ASQ certification a plus

 

                  

 

Boston Scientific is an Equal Opportunity Employer.

 

Posting Notes: [[filter2]]||US-CA-San Jose; US-MN-Maple Grove||Quality||[[mfield2]]


Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto

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