Central Engineering Services Director

Posting Date 3 days ago(11/24/2021 8:36 AM)
Requisition ID
2021-9909
Job Location(s)
Bloomington IN United States
Travel
10-20%
Position Type
Full Time
Company
Cook Medical Holdings
Category
Engineering

Overview

The Central Engineering Services Director at Cook Medical provides Engineering support for both the Research & Development (R&D) and Post Market Engineering functions globally, in the areas of testing, biocompatability, Engineering Operations, Computer Aided Engineering (CAE), materials, packaging and sterilization. 

 

This position is responsible for leading the team that provides Engineering support for both the Research & Development (R&D) and Post Market Engineering teams globally, as well as engineering teams at other Cook companies, in the areas of testing, biocompatibility, Engineering Operations, Computer Aided Engineering (CAE), materials, packaging and sterilization.

Toxicology & Biocompatibility:

  • Coordinate the global Toxicology / Biocompatibility teams at each Cook entity and ensure that the procedures and process for assessment and testing are sufficient to meet regulators requirement and are being applied consistently throughout Cook.
  • Engage with industry, and regulatory standards development working groups to help shape the future requirements for Biocompatibility, and Restrictive Substances.

Systems & Processes:

  • Develop a roadmap of the systems and processes need to enable the execution global and local pre and post market engineering work efficiently and consistently, such that the outputs can translate efficiently from the premarket to post market sustaining teams.
  • Support the Systems & Processes team in the development of these systems, ensuring stakeholder engagement, clear communication, removal or roadblocks.

Management Material and Regs

  • Establish and administer the processes for collecting the data on the raw materials used in our devices and needed to meet the requirements of global regulators.
  • Keep abreast of changes on regulations regarding materials data and restricted materials.
  • Establish systems that allow this data to be catalogued, easily accessed and kept up to date.

Materials Development

  • Provide subject matter expertise and support to Cook engineering personnel globally in the area of polymers, polymer processing, metallurgy, etc.

Sterilization and packaging

  • Provide subject matter expertise and support to Cook engineering personnel globally on the development and validation of packaging and sterilisation
  • Engage with industry, and regulatory standards development working groups to keep abreast of changes in regulations around sterilisation and emerging technologies and techniques for sterilisation.

In Vitro and In Vivo testing

  • Manage our testing teams at Cook Research Institute (CRI)
  • Coordinate the testing teams and labs at other Cook Medical entities to ensure our global testing teams are developing the capabilities necessary to effectively serve our global engineering teams
  • Establish and maintain systems and procedures that allow all our global test teams to execute their work in a common manner.

Responsibilities

• Ensure that adequate resources are available for execution of all engineering activities required to support R&D and Post Market Engineering efforts globally
• Collaborate with global leadership of Corporate Operations, R&D and Post Market Engineering to establish the strategic direction of the Central Engineering Services team, as well as manage and prioritize workload
• Collaborate with R&D and Post Market Engineering to establish and maintain procedures, processes and tools to support the efficient completion of design control and risk management activities
• Establish processes to ensure operational compliance with all applicable company, regulatory and industry standards and define approach to achieve compliance effectively and efficiently
• Define metrics to appropriately measure the effectiveness of the Central Engineering Services team and a mechanism to communicate progress against these metrics to relevant stake holders

• Assure functional costs are tracked and managed within budgetary constraints
• Develop and justify plans for staffing and equipment to fulfill service provision requirements
• Work with industry leadership groups to influence future standards and practices.
• Establish an network of vendors that can support and supplement the work of the CES team
• Build, develop and manage the performance of the team
• Foster and maintain a workplace culture respectful and supportive of individual differences
• Ability to establish a culture of continual improvement and drive efficiency gains while maintaining quality and compliance
• Strong ability to collaborate with other functional leadership to achieve established objectives

Qualifications

• Minimum Bachelor's degree required in Engineering, preferably in Mechanical, Chemical, Industrial, or Biomedical Engineering
• Masters/PhD Degree preferred
• Minimum 10 years experience in the medical device field
• Minimum 7 years experience in Engineering management

• Strong technical, statistical, computer and analytical skills, demonstrated by achievements in lean or other process improvement methodologies
• Significant experience working directly with cross functional teams
• Broad knowledge and understanding of regulatory requirements, medical device quality systems, design controls, risk management, sterilization, materials and human anatomy

 

Physical Requirements:

• Must be able to perform the essential functions of the job, with or without reasonable accommodations
• Majority of work is performed in a normal office environment

• Ability to travel globally to interact with all R&D, Post Market Engineering, Manufacturing location management and Corporate executives

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