Jobid=ef3e4137c8a1 (0.1014)
Job description
We are seeking an experienced Manufacturing Engineer to join our operations team as a consultant, bringing proven expertise in process stability, continuous improvement, and production support. In this role, you will ensure that manufacturing processes are reliable, efficient, and ready for volume production—minimizing disruptions and maximizing yield.
You’ll act as a technical expert during critical phases of product lifecycle management, supporting process validation, change implementation, and root-cause resolution. If you’re a hands-on engineer with a strong quality mindset and a track record in high-tech production environments, this is your opportunity to drive measurable impact.
Key Responsibilities
- Support, maintain, and improve manufacturing processes to ensure high yield, reliability, and operational continuity.
- Minimize production disturbances by collaborating with team leads, troubleshooters, and development teams to resolve root causes.
- Lead the replacement and qualification of critical equipment and processes to ensure business resilience.
- Develop, update, and maintain work instructions, process documentation, and standard operating procedures.
- Monitor, maintain, and qualify production tooling, fixtures, and devices to ensure process consistency.
- Train and instruct production personnel on processes, changes, and improvements.
- Support and execute process validation activities, ensuring compliance with quality and regulatory standards.
- Drive structural improvements using problem-solving methodologies such as 8D, PR (Problem Reports), CAPA, FMEA, and SPC.
- Lead the implementation of product and process changes through Lifecycle Management and Modify Launched Design workflows.
- Conduct root cause analysis for Defect On Arrival (DEFOA) and Missing On Arrival (MOA) issues, and implement corrective actions.
- Analyze production performance data using Six Sigma, Statistical Process Control (SPC), and other data-driven techniques.
- Lead or contribute to efficiency, quality, and cost improvement projects, applying DMAIC and Green Belt-level methodologies.
- Support New Product Introductions (NPI) by preparing trial runs, providing feedback to industrialization teams, and ensuring smooth ramp-up.
- Contribute to NPI project planning and execute preparation activities for prototype and pilot production.
- Participate in internal and external audits as a manufacturing process expert.
- Lead escalation responses for critical production issues in collaboration with development and other stakeholders.
Qualifications & Skills
- Bachelor’s degree in Industrial Engineering, Electronics, Applied Physics, Mechatronics, or a related technical field.
- Minimum 2 years of experience in manufacturing, process engineering, or industrial operations within a high-tech or medical devices environment.
- Hands-on mentality with strong attention to detail and accuracy in documentation and execution.
- Proactive, independent, and results-driven—able to take ownership and manage stakeholders effectively.
- Solid understanding of quality management systems and practices (e.g., ISO 9001, ISO 13485, FDA requirements).
- Experience with quality tools: FMEA, 8D, CAPA, SPC, root cause analysis.
- Proficiency in process validation and change management within regulated environments.
- Familiarity with MES systems (e.g., SAP) and PLM tools (e.g., Windchill) is preferred.
- Basic knowledge of Operational Technology (OT) and Information Technology (IT) systems in production environments.
- Demonstrated ability to analyze data, identify trends, and summarize findings for technical and managerial audiences.
- Strong communication and interpersonal skills—able to interact effectively with operators, engineers, and management.
- Fluent in English & Dutch.
Preferred Attributes
- Six Sigma Green Belt certified (or equivalent), with applied experience in process improvement projects.
- Experience in medical device, aerospace, automotive, or other regulated industries.
- Understanding of digital manufacturing, Industry 4.0 concepts, or data connectivity in production.
- Ability to lead cross-functional improvement initiatives and mentor junior team members.
- Customer-first mindset with a focus on reliability, safety, and long-term product performance.
Deel deze vacature: