Boston Scientific Design Quality Senior Supervisor 

United States, Minnesota, Maple Grove 

418573788

Your responsibilities include:

• Supervise up to 5 direct reports (engineers and/or technicians) in design quality including assignment and operational oversight of small to medium projects within the sustaining organization.
• In-depth understanding and application of Design Control and Risk Management concepts. Provide quality and compliance input to project teams & mentoring to direct reports for project decisions and deliverables.
• Support the execution and documentation of Design Validation & Verification and Usability activities.
• Lead and participate in Design Quality initiatives. Influence implementation of quality system changes/requirements to commercial devices.
• Creation and review of Risk Management documentation such as Hazard Analysis, Task Analysis, Design Failure Mode, and Effects Analysis (DFMEA) and Fault Tree Analysis (FTA). Understand and support linkage of product performance data and Risk Management.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues (i.e. 5 Whys analysis, Is-Is Not analysis, DMAIC problem solving methodologies).
• Provide quality guidance to assure country specific compliance.
• Champion compliance to company policies, work instructions and SOPs.
• Provide quality and compliance input for post market product sustaining activities, such as design changes, customer complaint investigations, NCEP’s, CAPA’s PIRs, Field Signals Evaluations and Field Actions.
• Support internal and external regulatory audits as required.
• Assist technicians in maintenance and management of shared spaces & procedures that support commercial execution and new product development projects (RTSL, sorting room, mezzanine storage).
• Support collection and analysis of key quality trending information and data for Management Review and Complaint Reviews. May present product performance at SER/CRB.
• Distinguish work responsibilities between design quality and cross functional roles (technical writers, technicians, engineers, DQA, R&D, PM, Packaging/Labelling, etc.)

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

• Bachelor’s degree in Chemical, Mechanical, Electrical or Biomedical Engineering, or equivalent.
• 5 years of design control and risk management experience
• 5 years medical device experience
• ISO 13485, ISO 14971, CFRs, and Quality System Regulations understanding & demonstrated use
• Strong communication skills (verbal & written) and presentation skills
• Problem solver, capable of facilitating the problem-solving process & driving issues to closure
• Excellent organizational and planning skills; drives for results
• 1+ years of direct or indirect supervisory experience
• Travel approximately <10%

Preferred Qualifications:

• Focus on detailed work with emphasis on accuracy and completeness
• Ability to collaborate and work on a highly matrixed and global team
• Established supervisorial or equivalent leadership experience
• Experience with Class III Medical Devices
  

Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement. The goal of the drug testing is to increase workplace safety in compliance with the applicable law.

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.