Job Title: Senior Manufacturing Engineer
We are seeking a highly skilled and experienced Senior Manufacturing Engineer to join our expanding engineering team. This is an exciting opportunity for a motivated individual to play a key role in optimizing, supporting, and advancing manufacturing processes.
Key Responsibilities:
* Collaborate with cross-functional teams to develop and improve manufacturing processes.
* Develop and implement manufacturing systems and strategies to achieve cost, quality, and time objectives.
* Identify and implement opportunities to optimize/improve manufacturing processes using Lean methodologies.
* Analyze and resolve complex manufacturing issues (e.g., CAPA, non-conformances, audit observations).
* Develop and maintain operational processes and procedures incorporating industry best practices and regulatory requirements.
Requirements:
* Degree level 8 in Engineering or related discipline with 5+ years of relevant experience.
* Green Belt certification is a distinct advantage.
* Experience with medical device process and manufacturing development, project/program management, risk analysis, and problem-solving skills.
* Knowledge of design verification and process validations.
* Excellent organizational and interpersonal skills, a dynamic team player, and proactively working on cross-functional teams.
* Good understanding of lean principles and methodology.
* Excellent understanding of ISO 13485 and FDA processes.
* Experience with statistical techniques (DOE, Six Sigma).