Manager, Sustaining Engineering

Introduction

Is This The Role For You?

We hire smart people with big hearts. People who have a passion for their work and who strive every day to help others. Our work requires bold and innovative leaders; people who bring strong values and ethics to their role.

If you’re ready for a career that allows you to grow and develop into the professional you want to be – today and in the future….CryoLife is the place for you.

Position Overview

The Manager of Sustaining Engineering will coordinate and manage engineering support to: meet product performance specifications and manufacturing goals; develop and maintain manufacturing documentation and labeling; troubleshoot and resolve production problems; and develop and support production outsourcing and materials vendors. This person will work with production, quality and regulatory groups to develop, qualify and implement new or improved processes and coordinate engineering responses to Non-Conformances, CAPA, complaints, technical questions and regulatory reviews.

Responsibilities
  • Foster a culture of engineering excellence.
  • Provide coaching, guidance, and performance feedback to engineers.  Facilitate professional development to enhance employee growth opportunities and output.
  • Lead initiatives within Operations to ensure accurate project prioritization and follow-up on timelines.
  • Manage the workflow of engineers within the scope of assigned projects to ensure project plans adhere to agreed-upon timelines and budget.
  • Delegate and manage tasks among team members as appropriate to their skill level and risk to the assignment.
  • Establish and support a work environment/culture of continuous improvement that supports company-wide productivity improvement initiatives.
  • Lead engineering activities to identify, qualify and implement new equipment and processes.
  • Mentor other engineers and participate on cross-functional Lean Six Sigma teams to enhance quality and efficiencies of manufacturing processes.
  • Develop high-level plans, schedules, resource assignments, and budgets for larger sustaining projects that reduce product cost, improve product quality and increase production capacity.
  • Work closely with peers in Quality and Regulatory organizations to share best practices, to develop engineering standards and processes, and to maintain a close working relationship to those outside the department.
  • Coordinate with other departments to support design changes and line extensions, including validations, biocompatibility, shelf life and other design verification and validation tests.
  • Manage engineering support to identify and support production outsourcing and materials vendors, including qualifications associated with vendor changes.
  • Oversee development and maintenance of manufacturing documentation by engineering to include specifications, drawings, procedures, labeling and packaging.
  • Coordinate engineering responses for Non-Conformances, CAPA, complaints, technical questions and regulatory reviews.
  • Provide technical support for analysis of field failures and customer returns.
  • Responsible for identifying, justifying and requisitioning new capital as required.
  • Ensure employees are trained to do their work and their training is documented.
  • Conduct performance reviews and recommend appropriate salary increases of personnel within the department.
  • Maintain the highest ethical standards, even when challenged from above.
  • Understand and uphold CryoLife Core Behaviors of Transparency, Integrity, Customer Focused, Inspires Others and Results Driven.

Other responsibilities as assigned. 

Qualifications
  • Bachelor’s Degree in Engineering or related field
  • At least 5 years of experience within medical device or related manufacturing operation
  • Previous supervisory or management responsibility preferred
  • Excellent teamwork skills and motivation to help others
  • Must have excellent oral and written communication skills
  • Lean Six Sigma Green Belt Certified (Black Belt preferred)
  • Comprehends Mechanical & Electrical drawings for Equipment and Facilities
  • Inherent vision for production improvements
  • Ability to manage and prioritize multiple tasks to completion
  • Ability to screen, interview, and select appropriate personnel
  • Ability to make decisions quickly in stressful situations
  • Ability to anticipate needs and ensure they are planned for
  • Ability to motivate staff to achieve excellence
  • Must be legally authorized to work in the United States
  • Must be willing to submit to a pre-employment background check and drug screen
  • Must be at least 18 years of age
Company Info

Who We Are.

CryoLife is one of the world’s leading contemporary medical device companies whose technology and products bring restoration and hope to people all around the world. With a variety of innovative products and technologies available, including preserved human cardiac and vascular tissues, surgical adhesives and sealants, and mechanical heart valves, our mission is to restore the health of patients by delivering innovative technologies of unsurpassed quality. Since our inception in 1984, it is estimated that our products and tissues have been implanted in over 1 million patients worldwide. Headquartered in Kennesaw, Georgia, CryoLife employs over one thousand people from various education and experiential backgrounds across the United States and internationally.

CryoLife is an Equal Opportunity/Affirmative Action employer.

CryoLife provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Reasonable Accommodations

CryoLife is committed to providing reasonable accommodations both in the application and interview process, consistent with legal requirements. If you need a reasonable accommodation while seeking employment, please email ADA_Accommodation@CryoLife.com or call 770-429-5215. A Human Resources representative will return your call. Messages or emails for any reason other than accommodation requests will not be returned.

Company
CryoLife, Inc.
Posted
10/06/2021
Type
Full time
Salary Range
$105,000.00 - 167,000.00
per Year
Salary range estimated by
Location
Austin, TX 78752, US
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