Manufacturing Engineer

Our client in Bishopstown are looking to add a Lead Manufacturing Engineer to their growing team.

Our client have developed a breakthrough single-use medical device, Solo+ TTD that addresses pain points of the current treatment of the surgical tympanostomy, a procedure that drains out the excess fluid built up in the ear. The surgical tympanostomy is the most common procedure done on children.

Main Purpose and Objective of the Position:

Reporting to the Director of Quality and Engineering, you will be responsible for interacting with current contract manufacturing facilities to ensure product supply to the market. You will also be responsible for the introduction of new equipment and processes to improve cost of goods and increase annual volumes.

Responsibilities:

• Collaborating with cross-functional teams and external manufacturers to develop and implement new manufacturing processes.
• Optimising existing manufacturing processes to improve productivity, quality, and cost-effectiveness.
• Designing, developing, and implementing manufacturing processes, including equipment selection, layout, and validation activities.
• Conducting risk assessments and implementing appropriate corrective and preventive actions.
• Leading process validation activities, including IQ, OQ, and PQ protocols.
• Developing and documenting manufacturing procedures, work instructions, and quality standards to ensure compliance with regulatory requirements.
• Providing technical support and troubleshooting expertise to resolve manufacturing issues.
• Participating in the design transfer process from R&D to manufacturing.
• Collaborating with suppliers to ensure the availability of high-quality components and materials.
• Collaborating with suppliers to evaluate and select materials, components, and equipment, ensuring the highest quality and cost-effectiveness.
• Implementing and managing process controls, including statistical process control (SPC) techniques, test method validation and process validation activities.
• Identifying and implementing automation and technology advancements to improve efficiency, productivity, and quality in manufacturing operations.
• Ensuring compliance with relevant regulatory standards, such as FDA regulations and ISO requirements.

• Bachelor's or Master's degree in Engineering or related field.
• Solid experience in medical device manufacturing, operations, and engineering.
• Strong knowledge of manufacturing processes, including assembly, testing, and packaging.
• Strong Experience with quality management systems and regulatory requirements for medical devices.
• Proficiency in process validation, risk management, and statistical analysis techniques.
• Excellent problem-solving skills and the ability to analyse complex manufacturing issues.
• Strong communication and interpersonal skills to collaborate effectively with cross-functional teams.
• Detail-oriented with a commitment to maintaining high standards of quality and compliance.
• Experience with Lean Six Sigma methodologies is a plus.
• Knowledge of CAD software and experience in design for manufacturability (DFM) is desirable.