28 days old
2017-12-222018-01-21

Engineer 3, Automated Systems Project Engineering

Terumo BCT
Lakewood, Colorado 80215
  • Job Code
    10686
  • Job Type
    Employee
  • Job Status
    Full Time

JOB SUMMARY

Position is responsible for technical leadership, managing to project schedules and individual engineering contributions in support of expansion of medical device manufacturing capabilities. Scope of work includes but is not limited to: directing resources internal and external to the organization, documentation of system requirements, oversight of design and machine build, development of machine control software, HMIs and data collection networks, acceptance testing, installation, qualification and training at site location. Engineering resources will be based in Denver Colorado, requiring travel to vendors and manufacturing site.  

 

ESSENTIAL DUTIES

  • Design, installation and validation of automated systems for medical device manufacturing in a clean room environment.
  • Assumes accountability for delivery of complete manufacturing systems; starting with design inputs, concluding with design transfer.

  • Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.

  • Implements and understands FDA or regulatory requirements as necessary.

  • Applies principles of current technologies to multiple tasks. Working knowledge of cross-functional and related technical areas.

  • Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.                 

  • Advises team members pro-actively on technical ideas and promotes skill development of team work.

  • Interacts with peers across projects to secure resources and commitments.

  • Handles frequent inter-organizational and outside customer contacts. Represents the organization in providing solutions to difficult technical issues associated with specific projects.

  • Follows technical specification requirements and provides feedback on various technical processes and procedures.

  • Presents effectively complex technical information/analysis, and responds to questions from technical staff members and management.   

  • Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).

Requirements

OTHER DUTIES AND RESPONSIBILITIES

  • Work direction responsibility may include technicians and junior engineers.

  • May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

  • Travel to domestic suppliers and manufacturing site, located in Vietnam, expected 10% - 15% of project duration.

 

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

  • Bachelor of Science Degree in Engineering, preferred.

 

Experience

  • Minimum 6 years experience specifying, building and qualifying manufacturing systems.

  • Two years of GMP manufacturing experience required.

  • Support and development of manufacturing operations off shore.

     

Skills

  • Requires demonstrated skills in technical innovation, technical leadership, mechanical and electrical systems.

  • Preferred experience with Allen-Bradley machine control systems.

  • Ability to define process requirements from broad customer base.

  • Experience with design, commissioning and qualification of complex, automated manufacturing systems.

  • Strong interactive skills in general communication, cross-functional participation and influence, mentoring and acceptance of guidance, technical leadership, project management, coordination with cross-functional team member, team behavior, and support for subordinates, junior engineers, technicians, and management.

  • Strong technical problem solving skills.

  • Mechanical and electronic aptitude to assist with equipment trouble-shooting.

  • Understanding of and adherence to GMP practices and FDA regulations.

  • Knowledge and ability to implement FDA or regulatory requirements as necessary.

  • Demonstrated ability to communicate effectively both verbally and in writing.

  • Knowledge and use of relevant PC software applications and skills to use them effectively.

 

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

General Labor Environment requirements include: use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

 

Additional Physical Requirements

Requires travel based on business needs.

 

Categories

  • Circuits and Systems
  • Control Systems
  • Instrumentation and Measurement
  • Lasers and Electro-Optics
  • Management

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Engineer 3, Automated Systems Project Engineering

Terumo BCT
Lakewood, Colorado 80215

Share this job

Engineer 3, Automated Systems Project Engineering

Terumo BCT
Lakewood, Colorado

Separate email addresses with commas

Enter valid email address for sender.

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast