Job Title:
Senior Manufacturing Specialist
This role involves overseeing the optimization, support and advancement of manufacturing processes through the application of technical expertise and lean principles.
* Collaborate 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 as this is an integral part of the role.
* 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 to qualify and validate manufacturing processes; analyze results, make recommendations and develop reports.
* Analyze and resolve complex Manufacturing and Compliance issues.
* Develop training and documentation materials for production to enable seamless knowledge transfer of project and manufacturing processes.
* Work with internal team members to explore new technologies, assessing 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).