Senior Manufacturing Engineer Role Overview
The Senior Manufacturing Engineer will be integral to optimizing, supporting, and advancing manufacturing processes through the application of technical expertise and Lean principles.
This is an exciting time to join a company as they transition from an R&D focused organization into a more operational one.
The Senior Manufacturing Engineer will work on setting up new manufacturing lines as they bring these processes in-house.
Key Responsibilities:
* Collaborating with other engineers and production teams to develop and improve manufacturing processes.
* Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives.
* Identify and ensure implementation of opportunities to optimize/improve manufacturing processes using Lean methodologies.
* Apply structured problem-solving techniques to process, material or equipment issues while offering manufacturing or quality ideas from experience.
* Develop and maintain operational processes and procedures incorporating industry best practices and in compliance with appropriate regulatory requirements.
* Perform process analysis and identify areas for improvement, recommending and implementing solutions to enhance productivity and efficiency.
* Develop complex experiments and tests (including writing and executing protocols) to qualify and validate manufacturing processes; analyze results, make recommendations, and develop reports.
* Analyze and resolve complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations).
* Develop training and documentation materials (e.g., work instructions) for production to enable the seamless knowledge transfer of project and manufacturing processes.
* Work 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 – additional relevant qualifications may be advantageous.
* 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 who can work effectively and proactively on cross-functional teams.
* Excellent organizational and interpersonal skills, a team player, proactive and likes to take ownership of tasks/projects.
* Good understanding of lean principles and methodology (e.g., DMAIC, Kaizen, Value Stream Mapping).
* Excellent understanding of ISO 13485 and FDA processes.
* Experience with statistical techniques (DOE, Six Sigma).
* Proficiency with engineering software (e.g., AutoCAD, SolidWorks).