Senior Manufacturing Engineer

Engineering duties and responsibilities:

Work within the NPI team with responsibility for project engineering related activities, including, but not limited to the following:

· Provide design for manufacturing technical feedback to global design groups – Conduct and lead detailed product design reviews.

· Lead NPI manufacturing process design, development and process characterization activities.

· Successfully integrate new technologies and processes into existing manufacturing operations ensuring good performance metrics and capacity opportunities.

· Design, develop and source tools, fixtures and special equipment for manufacturing processes.

· Develop new technologies delivering driving process efficiencies and continuous improvement.

· Lead validation strategy for Equipment and Process qualification & Execution of these validations.

· Deliver stable manufacturing solutions in line with business metrics.

· Lead the development and implementation of process improvements.

· Provide key inputs and leadership into transformational process developments.

· For new products, ensure the efficient and timely transfer of product and process knowledge to Process Engineering.

· Development of capacity plans, understand constraints, develop capital plans where appropriate.

· Project planning to deliver project(s) against agreed time lines and project scope.

· Project Management - provide timely and accurate reporting on project activities.

· Lead risk management activities.

· Active member of multifunctional process and production improvement team delivering new product introduction and value/growth programs.

· Develop and maintain an environment of continuous improvement and process excellence

· Support the management and justification of capital investment requirements in line with business growth

· Resolve equipment layouts for manufacturing cells supported by Lean and Operations teams

· Performs other related duties, as required.

Professional experience requirements:

· Previous experience in manufacturing and/or engineering is preferred.

· Previous experience working in a regulated industry, such as Medical Device is preferred.

Essential Criteria:

· Third level degree in Biomedical / Mechanical / Manufacturing Engineering or similar field.

· 3 years minimum (preferably 5 years plus) experience in a medical device or comparable hi-tech environment.

· Proven track record in the development, installation and qualification of manufacturing processes, preferably in Class II / III medical devices.

· Strong interpersonal and team skills.

· Demonstrated ability to lead sub teams within a project and give technical direction to fellow team members, contractors, vendors to complete tasks to a defined timeline.

· Skilled in preparing documentation such as validations protocols and reports, process documentation, risk analysis documentation.

· Excellent Planning & Organizing Skills including attention to detail, multi-tasking, critical thinking and problem solving.

· Flexible work ethic.

Desirable Criteria:

· Knowledge of medical device quality & regulatory systems and medical device directive (ISO13485, MDR and FDA 21 CFR 820) and other pertinent Design Control requirements.

· Knowledge of orthopaedic joint manufacturing processes.

Job type: Permanent Division: eTeam Workforce Limited Reference: 22-06931