Manufacturing Engineering Manager

A fast-growing global medical device company, developing and manufacturing innovative medical device looking for Engineering Manager to lead the Manufacturing Engineering team. The Engineering Manager responsible for optimizing, improving, and supporting the manufacturing processes for our medical products. The ideal candidate will have a strong background in technical process optimization, a deep understanding of single-piece flow production, understanding with single-use devices, and the ability to manage complex engineering activities.

Job Description:

• Lead and manage the Engineering team to continuously support and improve production processes.
• Optimize single-piece flow production to maximize efficiency, quality, and safety.
• Analyse and resolve production issues, ensuring consistent and reliable production output.
• Collaborate with cross-functional teams, including R&D, manufacturing, quality, and supply chain, to implement process improvements.
• Maintain compliance with regulatory requirements (FDA, ISO 13485) within the production process (incl. process validation) and technical documentation.
• Lead engineering change (ECO) projects and technical experiments as a part of related controlled processes implementation.
• Foster technical investigations and drive for root cause identification as a part of the NCMR process.
• Extending process and product engineering efforts to outsourced manufacturing of administration sets (single use sterile products), ensuring alignment with company standards and regulatory requirements.

Requirments:

• Bachelor's degree in Mechanical Engineering or a related field.
• Proven experience of a least 5-7 years in mechanical engineering and project management.
• Strong leadership and team management skills.
• Excellent problem-solving and analytical abilities.
• Proficiency in engineering software and tools.
• Knowledge of industry standards and regulations.
• Strong communication and interpersonal skills.
• Ability to manage multiple projects and priorities effectively.

Full Time

On-site