Creganna Medical

Engineering Manager (Medical Device/ Pharmaceutical)

Creganna Medical Date Posted: 20-Nov-2017

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Job Nature:
Permanent
Position Level:
Experienced, Manager
Qualification:
Bachelor's / Honours

Job Description

JOB SUMMARY

 

Directly responsible for a team of technical personnel providing a professional level of technical support, innovation, direction and leadership.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  Include the following. Other duties may be assigned.

 

  • Responsible for managing the Engineering Team and developing them to meet the challenging requirements of the Medical Device Industry.  Ensure a data driven, innovative culture and effective problem solving approach.
  • Works as part of the site management team to deliver on budget and site KPI commitments
  • Responsible for Environmental Health and Safety leadership at site
  • Drive improvement in equipment and facilities performance in a sustainable and methodical manner.
  • Manage a diverse array of Engineering related projects. 
  • Effectively manage the execution of engineering to deliver yield, NPI, cycle time and efficiency goals. 
  • Lead the site integration in to TEOA (TE Lean Production System)
  • Drive Engineering based Value Improvement and Cost Reduction projects.
  • Ensure that the group has a balanced skill-set of effective problem solvers, specialists and experience.
  • Liaise with all other departments and functions to ensure all Engineering expectations are met and delivered on time.
  • Proactively take independent action to resolve issues and improve existing processes.
  • Manage capital projects to ensure compliance, on time delivery, within budget and meeting specification with minimum disruption to business operations.
  • Plan, organise, direct and control project activities and resources to meet defined project, site and engineering objectives. 
  • Develop Engineering staff (i.e. continuing professional development).

 

 

SUPERVISORY RESPONSIBILITIES:  

 

Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.  

 

 

Education/Experience and Qualifications:

 

Degree in Engineering (or equivalent experience) and at least 10 years’ management experience with 4 – 5 years in a medical device manufacturing environment;

 

  • Preferably have at least 3 – 4 years of experience in catheter manufacturing and engineering;
  • Demonstrated proficiency utilizing engineering tools (i.e. FMEA, DOE, SPC, statistical tools, etc.);
  • Knowledge of GMPs, ISO 9001/EN 46001, ISO13485 and the Medical Device Directives;
  • Prior manufacturing and product transfer experience;
  • Preferably, Certified Six Sigma Green / Black Belt;
  • Possess good coaching/mentoring skills;
  • Excellent communication skills and have demonstrated the ability to lead in a previous role;
  • Experience in people management and development with strong team building skills with proven abilities in decision making and sound personal judgements;
  • Extensive process validation experience, preferably with knowledge of TMV and DV
  • Have the ability to implement Process Capability and Lean Principles in every aspect of Engineering. Knowledge of ISO and FDA compliance a definite advantage;
    • Computer literate in Microsoft Office applications.

 

Work Environment:

 

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.  Controlled Environment (Class 100K cleanroom) and office area.

JOB SUMMARY

 

Directly responsible for a team of technical personnel providing a professional level of technical support, innovation, direction and leadership.

 

 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  Include the following. Other duties may be assigned.

 

  • Responsible for managing the Engineering Team and developing them to meet the challenging requirements of the Medical Device Industry.  Ensure a data driven, innovative culture and effective problem solving approach.
  • Works as part of the site management team to deliver on budget and site KPI commitments
  • Responsible for Environmental Health and Safety leadership at site
  • Drive improvement in equipment and facilities performance in a sustainable and methodical manner.
  • Manage a diverse array of Engineering related projects. 
  • Effectively manage the execution of engineering to deliver yield, NPI, cycle time and efficiency goals. 
  • Lead the site integration in to TEOA (TE Lean Production System)
  • Drive Engineering based Value Improvement and Cost Reduction projects.
  • Ensure that the group has a balanced skill-set of effective problem solvers, specialists and experience.
  • Liaise with all other departments and functions to ensure all Engineering expectations are met and delivered on time.
  • Proactively take independent action to resolve issues and improve existing processes.
  • Manage capital projects to ensure compliance, on time delivery, within budget and meeting specification with minimum disruption to business operations.
  • Plan, organise, direct and control project activities and resources to meet defined project, site and engineering objectives. 
  • Develop Engineering staff (i.e. continuing professional development).

 

 

SUPERVISORY RESPONSIBILITIES:  

 

Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.  

 

 

Education/Experience and Qualifications:

 

Degree in Engineering (or equivalent experience) and at least 10 years’ management experience with 4 – 5 years in a medical device manufacturing environment;

 

  • Preferably have at least 3 – 4 years of experience in catheter manufacturing and engineering;
  • Demonstrated proficiency utilizing engineering tools (i.e. FMEA, DOE, SPC, statistical tools, etc.);
  • Knowledge of GMPs, ISO 9001/EN 46001, ISO13485 and the Medical Device Directives;
  • Prior manufacturing and product transfer experience;
  • Preferably, Certified Six Sigma Green / Black Belt;
  • Possess good coaching/mentoring skills;
  • Excellent communication skills and have demonstrated the ability to lead in a previous role;
  • Experience in people management and development with strong team building skills with proven abilities in decision making and sound personal judgements;
  • Extensive process validation experience, preferably with knowledge of TMV and DV
  • Have the ability to implement Process Capability and Lean Principles in every aspect of Engineering. Knowledge of ISO and FDA compliance a definite advantage;
    • Computer literate in Microsoft Office applications.

 

Work Environment:

 

While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.  Controlled Environment (Class 100K cleanroom) and office area.

Company Overview

Creganna Medical
Creganna Medical
Creganna Medical is ranked among the Top 10 global companies in the medical device outsourcing industry and specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilitie…