Senior Production Engineer

at  Planet Innovation

As part of our continous growth, we are looking for a Senior Production Engineer with cleanroom product development or manufacturing experience to join our New Production Introduction (NPI) team.

THE ACCOUNTABILITIES

• Leads the establishment and maintenance of manufacturing processes
• Leads initiatives to improve the manufacturing process with a focus on lean assembly and manufacturing processes
• Supports junior engineers in the resolution of product manufacturing issues
• Support, mentors and guides less experienced production engineers in the DFM, establishment and implementation of new product introduction
• Successful preparation of reports of key metrics and communication with client and key stakeholder relationships at a peer technical level
• Development of plans, schedules, improvements for review and approval by Manager
• Reporting of progress and status to agreed forecasts, plans and agreed outcomes
• Technically responsible for product drawings, process flow charts, design reviews and feasibility risk assessments including relevant engineering documentation for products such as PFMEA, BOMs and SOPs
• Participate in assembly processes within the manufacturing plant
• Assessment and qualification of suppliers, including low cost regions
• Management of materials, non-conformances and supplier improvements within the CAPA system
• Ensure compliance with ISO 13485 manufacturing processes
• Regular interfacing with engineers, suppliers and customers
• Significant role in audit and qualification of suppliers and manufacturing processes

THE TYPICAL EXPERIENCES

• 8+ years’ experience within manufacturing function in engineering discipline.
• Experience in new product DFM, establishment, and introduction into manufacturing
• Knowledge of lean cleanroom assembly and manufacturing techniques
• Knowledge of PI engineering discipline framework, standards and methodologies
• Compliance with PI policies; procedures and international quality standards, including ISO 13485, ISO 9001 or having worked in a regulated industry
• Experience working to policies; procedures and international quality standards, including ISO13485, ISO9001, or in a highly regulated industry
• Bachelor’s in Engineering (in appropriate discipline i.e. Mechanical; Electronics)

A Senior Production Engineer leads projects to establish or improve the manufacturing processes of a range of technically complex products (both medical and non-medical devices).
They focus on understanding the technical and regulatory background of both product and process to ensure informed decisions are made in an efficient manner and are responsible for providing guidance to less experienced engineers on a broad range of manufacturing fundamentals.