Engineering Manager

Engineering Manager - Start up Medical Devices

Ref No.: GJ07740xy

Location: Galway, Mayo

Salary:

Experience required: 9 - 10 years

Job Type: Permanent



Summary: Our client is looking for an Engineering Manager for a Start Up Medical Device Comapany based in Galway.



Description:

Engineering Manager - Start up Medical Devices

Our client is looking for an Engineering Manager for a Start Up Medical Device Comapany based in Galway.

Responsibilities:

To provide technical leadership and strategic direction during the Design, Installation and Commissioning of new production lines, products and technology. To provide ongoing technical support and process improvements to manufacturing. To identify and follow through on new processes, innovation and commercial opportunities

Start Up: Represent Engineering Dept by providing resources, technical knowledge and expertise. Set goals and objectives and timelines for completion. Provide reports and updates on progress on key metrics.

Manufacturing Support: provide timely support and technical solutions to manufacturing issues.

Process Improvement: Identify areas and means to improve manufacturing processes and product quality using Lean Six Sigma principles.

Maintenance Management: Design and implement a quality maintenance program to ensure all equipment is maintained and calibrated; ensuring equipment/manufacturing downtime is minimal

Equipment Commissioning: Design the specification and purchase of capital equipment, ensuring balance between optimising technological capabilities and return on investment

Validation: Liaise with Quality Dept to ensure all new equipment is validated as per MVP. Provide resources to participate in OQ/PQ and IQ activities

Personnel: Liaise with HR Dept to build an effective engineering team by taking responsibility for recruitment and selection, learning and development and performance management of all engineering staff.

Project Management: Monitor and control progress of projects to ensure sound application of engineering principles are used and design control procedures are being followed/achieved

Engineering Budgets: Liaise with Finance in agreeing engineering budgets, manage annual budget/expenses and seek cost improvements wherever possible.

Contract Engineering Services: To identify external engineering requirements, source and manage all external contractors

Requirements

Degree or higher qualification in Mechanical, Production, Manufacturing or Biomedical Engineering.

Management/Supervisory qualification would be an advantage

Lean Six Sigma and TPM knowledge and experience

10 years Medical Devices, including implants, coatings and orthopaedics

Good working knowledge of automated manufacturing equipment Good knowledge of regulatory expectations and industry practices e.g. QSR, ISO13485,

Proven capability in implementation of Process capability and Lean principles in every aspect of engineering.