Senior Process Engineer — Medical Device Process Optimization

Blue Medical Devices B.V. a Translumina Company; Helmond; On-site; EUR 60,000 - 80,000; Full time

Benefits offered by this job

Salary €60,000–€80,000 per year

28 vacation days

Pension scheme

Education budget & training

Relocation allowance

Canteen

Job summary

Blue Medical Devices is seeking an experienced Mid-Level / Senior Process Engineer to analyse, improve and future-proof production processes within a highly regulated medical-device manufacturing environment. You will improve process performance, product quality, reliability and efficiency, translating production data, deviations and technical challenges into robust, validated processes.

You will work closely with Production, Engineering, R&D, QA/RA, QC and international colleagues within our

Qualifications

• 8+ years of relevant experience as Process/Manufacturing Engineer or similar
• Senior level: 6+ years on complex projects
• Experience with process development, optimization and validation
• Experience with CAPA, FMEA, risk management and change control
• Knowledge of ISO 13485, MDR or similar standards
• Willingness to work on-site in Helmond and on full-time basis
• Strong analytical mindset and structured approach

Responsibilities

• Analyse and improve production processes, yield, OEE and KPIs
• Identify bottlenecks, risks and deviations and implement solutions
• Perform root cause analyses, impact assessments, CAPAs and risk analyses
• Develop, optimise and embed production processes
• Prepare validation protocols, reports and work instructions
• Manage change controls and assess changes to processes, tooling and materials
• Contribute to risk assessments and verification of risk-control measures
• Support transfer of new or modified processes and technologies
• Plan and lead improvement projects and subprojects
• Perform statistical analyses and translate data into actions
• Provide technical advice to Production, Quality and other stakeholders
• Document and transfer knowledge through training

Skills

Process improvement

Root cause analysis

Statistical methods

Quality Management System

English proficiency

Dutch learning willingness

Education

Bachelor’s or Master’s degree in a technical discipline

Tools

Minitab

Job description

Blue Medical Devices is seeking an experienced Mid-Level / Senior Process Engineer to analyse, improve and future-proof production processes within a highly regulated medical-device manufacturing environment. You will improve process performance, product quality, reliability and efficiency, translating production data, deviations and technical challenges into robust, validated processes.

You will work closely with Production, Engineering, R&D, QA/RA, QC and international colleagues within our