Senior Product Engineer

6 days ago
Job ID
2017-1907
US-TX-Austin
# of Openings
1
Category
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

Provide expert engineering support for a range of products through all phases of product development and manufacturing; bring new products on-line insuring desired functionality, efficient manufacture, and regulatory compliance; refine existing product processing in order to increase efficiency while maintaining required quality requirements; and troubleshoot and resolve production problems for assigned products.

Responsibilities

  • Interface with Production, Product Development and other appropriate functions to fully understand and suggest improvements to functionality, performance, and safety requirements of assigned products.
  • Coordinate and manage new product introduction schedule and activities, and cross-product issues throughout the product life cycle.
  • Identify, evaluate and coordinate the development and implementation of complex product manufacturing processes.
  • Coordinate work among Production, Quality Control, Process Engineering, and Quality Assurance to assure that required manufacturing and inspection steps for successful & efficient production of assigned products are properly defined, integrated, implemented & verified/validated.
  • Design, provide or review needed engineering drawings, specifications, procedures, methods, tooling, fixturing, or gaging for processing and inspecting assigned products.
  • Determine disposition of discrepant materials or components.
  • Ensure that acceptable raw materials and components required for supporting in-house production levels are received. This includes identifying new vendors and communicating engineering, quality, delivery, and regulatory requirements.
  • Analyze complicated Manufacturing related problems of assigned products, propose possible solutions and coordinate implementation of best solutions.
  • Develop, review and update risk assessment for assigned products.
  • Suggest and implement production changes to improve reliability, reduce cycle times and enhance yields.
  • Drive activities with manufacturing subcontractors to define and design processes and optimize results.
  • Communicate and provide expert opinion on technical product status to management, to include yield, manufacturing and quality issues.
  • Maintain expert knowledge of pertinent Manufacturing Technologies and disseminate this information as requested to various engineering and production groups

Additional Responsibilities:

  • Keep knowledge up to date regarding pertinent Manufacturing Systems and Processes; drawing standards; in house procedures, policies and specifications; GMP; ISO 9000 series and other appropriate regulatory requirements
  • Provide various product cost and implementation schedules.
  • Design and optimize substrate designs for complex carbon coated components.
  • Travel to vendors, trade shows and between CryoLife facilities, possibly overseas. 
  • Perform additional duties that may be assigned by Supervisor.
  • Relate to other people beyond giving and receiving instructions: (a) can get along with co-workers or peers without exhibiting behavioral extremes; (b) perform work activities requiring negotiating, instructing, persuading or speaking with others; and (c) respond appropriately to criticism from a supervisor.
  • Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency. 

Qualifications

  • Minimum of a Bachelors degree, preferable of a technical or manufacturing nature. An additional 8 years experience (16 years total) may be substituted for a Bachelors degree.
  • Minimum 8 years experience encompassing Engineering and Product Design with Medical Devices or other closely regulated products.
  • Needs to be well versed in A.N.S.I. drawing standards, CAD, mfg. processes, process control, engineering economics and project scheduling.
  • Detailed understanding of risk assessment and FMEA.
  • Demonstrated ability to take complex designs into production.
  • Experience in label and IFU design, including coordinating translations.
  • Green Belt in 5S/Lean Manufacturing preferred.
  • Self starter with strong leadership, communication skills and demonstrated problem solving ability. 
  • Ability to read, analyze, interpret and follow written instructions.
  • Ability to interpret and follow oral instructions.
  • Required to read, write and speak English with good command of the language,  and use moderately complex math.
  • Strong computer skills including at minimum, be adept in use of MS Office 2000 or later, internet, and electronic mail.
  • Strong interpersonal and communication skills.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Must have a valid driver’s license and a good driving record.  Employees in this classification must maintain insurability during the term of employment.

 

Physical Environment/ Working Conditions:

 

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 

While performing duties of this job, the employee is regularly required to

  • Talk, hear, sit, stand, bend, reach and move about facilities
  • Sit or stand for extended periods of time
  • Lift, bend forward with and/or move up to twenty (20) pounds

Note: This job description is not designed to cover or contain a comprehensive listing of functions, activities, duties or responsibilities that are required of the employee.

Company Info

Who We Are.

 

CryoLife is one of the world’s contemporary medical device companies providing preserved human cardiac and vascular tissues, surgical adhesives and sealants, cardiac lasers and implantable end-stage renal disease access grafts for the repair of complex cardiac and vascular reconstruction surgeries. Since the Company’s inception in 1984, it is estimated that its products and tissues have been implanted in about 900,000 patients worldwide.

 

CryoLife technology and products bring restoration and hope to people all around the world. CryoLife headquarters are located in Kennesaw, Georgia, a suburb of Atlanta.

 

CryoLife is an Equal Opportunity/Affirmative Action employer.

CryoLife is committed to the philosophy of equal opportunity employment. We do not discriminate against any employee or applicant.  All qualified candidates will receive consideration for employment without regard to race, ethnicity, age, religion, sex, sexual orientation, national origin, citizenship, disability, veterans or other legally protected status.

 

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.

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