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Introduction:

Reports To: Sr Manager Operations

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

Responsibilities:

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.

Drive improvement in equipment and facilities performance in a sustainable and methodical manner.

Manage a diverse array of Engineering related projects. Manage safety systems and processes.

Effectively manage the execution of engineering to deliver yield, NPI, cycle time and efficiency goals.

Ensure the execution of Lean manufacturing Principles throughout the plant.

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).

MANAGER RESPONSIBILITIES

Carries out supervisory responsibilities in accordance with the organizations 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.

Ensure environmental aspect and safety hazard risk assessments are identified, reviewed, carried out to remove or control the risks to their respective staff at the workplace.

Approve department environmental aspect, Risk Assessment and Safe Work Procedure if the risk is within acceptable level.

Provide and maintain a work environment which is safe and without risk to health for employees at work.

Report immediately all occupational accidents & incidents to the company and relevant parties and support the EHS Committee Management Representative in conduct of incident/accident investigation as appropriate.

Initiate and/or approve disposition actions for EHS nonconformance as well as corrective/preventive actions to prevent recurrences

Ensure that environmental, health & safety policies are upheld, EHS objectives and metrics are monitored, corrective/ preventive actions taken on EHS system defects are effective and properly closed.

Responsible for the safety, health and well-being of workers under their charge.

Provide support in EHS internal and external audits.

MANAGER AUTHORITIES

To enforce compliance to companys EHS management system and relevant legal and other applicable EHS requirements.

To delegate task/s to his/her subordinates.

To stop any unsafe work or negligent act that may endanger personnel.

To investigate and analyse any incidents that occurred within his/her charge

Requirements:

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

Must have at least 3 4 years of experience in balloon 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;

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.