Boston Scientific Principal Design Assurance Systems Engineer 

United States, Minnesota, Maple Grove 

153457674

About the role:
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 include:

• 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.

What we’re looking for in you:
Required qualifications:

• Bachelor’s degree in Engineering
• 7+ years of related experience
• Understanding of electrical safety standards IEC 60601
• Experience with reliability testing
• Understanding of configuration management
• Demonstrated use 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
• Medical device experience
• ASQ certification

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.