CIS Senior Manager - NMD

Boston ScientificArden Hills, MN
Onsite

About The Position

This is a unique opportunity for a strong leader to work on a high-performing and cross-functional environment leading the Electrophysiology Complaint Investigation team. This position will be based on Arden Hills and support the complaint investigation for Single Use Device and Capital Equipment including the rapidly growing Pulse Field Ablation (PFA) technology. He/She/They will interact with our design sites in Montreal, Waltham, Heredia, Arden Hills, and Manufacturing sites in Heredia and Arden Hills and with different Sourced Finished Medical Devices (SFMD)s.

Requirements

  • Minimum of a Bachelors degree in engineering or another related technical field
  • Minimum of 7 years of related quality/complaint investigation experience
  • Minimum of 3 years of direct management experience
  • Medical device experience or regulated industry experience
  • Experience leading both technical and non-technical teams
  • Regulatory compliance experience in the areas of medical devices
  • Experience with complaint investigation processes

Nice To Haves

  • Advanced degree in technical fields
  • Knowledge of continuous improvement tools (Lean, Six Sigma, Robotic Process Automation)
  • Familiarity with Post Market Acquisition integrations
  • Strong analytical skills
  • Demonstrated leadership ability
  • Passion for continuous improvement

Responsibilities

  • Recruit, coach and develop organizational talent
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
  • Lead a team of employees in the achievement of organizational goals. Coach, direct, develop and motivate a high performing team
  • Lead a team of employees responsible for in depth technical analysis and product trending and act as liaison between the CIS team and cross-functional partners (R&D, Manufacturing, Design Assurance, Supplier Quality)
  • Provides general guidance to the Product Returns supervision
  • Determine appropriate staff levels and schedules; work with key partners to understand priorities and plan resource allocation accordingly
  • Develop department budget, execute and monitor spend
  • Keep the organization's vision and values at the forefront of decision making and action.
  • Demonstrate effective change leadership
  • Build strategic partnerships to further departmental, organizational objectives and drive a high performing culture
  • Develop and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills
  • Monitor and ensure compliance with company policies and procedures. Assures that appropriate resources (personnel, tools, etc.) are maintained to assure compliance and adherence to the BSC Quality Policy
  • Lead quality team on product/system development projects of major magnitude and scope. Key Quality voice of influence on projects
  • Own and drive deliverables related to quality systems, product quality, and compliance Own and drives commercial product monitoring and all related product sustainment activities
  • Provide guidance, mentoring and resolution across site functions regarding quality system compliance
  • Develop and implements quality strategies; seeks innovative approaches to attaining quality goals
  • Ensure adherence to the Global Corporate Metrics for complaint investigations
  • Directly interface with internal and external audit activities

Benefits

  • Core and optional employee benefits offered by Boston Scientific (BSC)
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