Senior Manufacturing Engineer Position
Our client, a high potential medical device startup, is actively seeking a Senior Manufacturing Engineer to join their expanding engineering team. The successful candidate will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean methodologies.
Key Responsibilities:
* Collaborating with other engineers and production teams to develop and improve manufacturing processes
* Developing and implementing manufacturing systems and strategies to achieve cost, quality, and time objectives
* Identifying and ensuring implementation of opportunities to optimize/improve manufacturing processes using Lean methodologies
* Applying structured problem-solving techniques to process, material or equipment issues while offering manufacturing or quality ideas from experience
* Developing and maintaining operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements
* Performing process analysis and identifying areas for improvement, recommending and implementing solutions to enhance productivity and efficiency
* Developing complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyzing results, making recommendations, and developing reports
* Analyzing and resolving complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
* Developing training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes
* Working with internal team members to explore new technologies, assessing in terms of performance, cost, and reliability
Requirements:
* Degree level 8 in Engineering or related discipline with 5 years + relevant experience
* Green Belt certification is a distinct advantage
* Experienced with medical device process and manufacturing development and project/program management, risk analysis, and problem-solving skills
* Knowledge of design verification and process validations, particularly as it pertains to equipment and manufacturing processes
* Dynamic team player and can work effectively and proactively on cross-functional teams
* Excellent organisational and interpersonal skills, a team player, proactive, and likes to take ownership of tasks/projects
* Good understanding of lean principles and methodology
* Excellent understanding of ISO 13485 and FDA processes
* Experience with statistical techniques (DOE, Six Sigma)
* Proficiency with engineering software (e.g., AutoCAD, SolidWorks)
Benefits:
* Competitive salary and benefits package
* Opportunity to work with a dynamic and expanding engineering team
* Chance to make a real impact on the company's growth and success