Project Engineer, Brummen

This role combines hands‑on process optimization and continuous improvement with project management responsibilities for capacity expansion, new technology introduction, equipment implementation, and major improvement initiatives. The objective of the role is to improve manufacturing efficiency, yield, quality, and scalability while ensuring robust, validated, and compliant processes and technologies are successfully delivered to operations.

Responsibilities Essential Functions&Accountabilities: Process Engineering&Continuous Improvement

Develop, optimize, and standardize manufacturing processes, operating procedures, and work instructions to improve efficiency, yield, quality, and cost.

Draft and evaluate process improvement ideas aligned with operational and business objectives.

Perform risk assessments (e.g., FMEA) and support mitigation planning.

Execute optimization trials, data analysis, and statistical process monitoring.

Apply Lean Six Sigma and process excellence tools to drive sustainable improvements.

Assist in or lead structured problem‑solving for complex manufacturing and process issues.

Define, plan, and manage engineering projects related to capacity expansion, major continuous improvement initiatives, and new technology or equipment introduction.

Develop project charters, objectives, scope, timelines, and budgets; manage projects to successful completion.

Lead and coordinate cross‑functional, cross‑departmental, and inter‑company project teams, including external vendors and subject‑matter experts.

Support or lead vendor selection, specification development, and technical evaluation of new equipment and processes.

Work with vendors to refine functional and technical specifications, ensuring operations and process engineering requirements are met.

Support or lead factory acceptance testing (FAT), site acceptance testing (SAT), installation, and commissioning activities.

Support or lead equipment and process validation activities in line with regulatory and internal standards.

Provide post‑validation support during production ramp‑up, ensuring stable and effective process transfer to operations.

Documentation, Validation&Compliance

Develop specifications, validation protocols, and reports associated with processes and equipment.

Ensure project activities and process changes are documented in accordance with ISO 13485, FDA 21 CFR Part 820, and internal/global standards.

Monitor and report manufacturing and project performance metrics; present progress and results to management.

Training&Support

Provide technical guidance, training, and support to process engineering, manufacturing, and operations personnel on new or improved processes and equipment.

Support best‑practice sharing and alignment across facilities.

Travel: May be required to travel as needed, up to an estimated 10%.

Qualifications Knowledge, Skills and Abilities:

Strong knowledge and experience in a regulated medical device manufacturing environment (ISO 13485 and/or FDA 21 CFR Part 820).

Solid understanding of process design and development, equipment automation, installation, and validation.

Strong project management skills with experience managing multi‑disciplinary and multi‑site teams.

Experience with statistical process control, data analysis, and process monitoring.

Practical experience with Lean Six Sigma and continuous improvement methodologies.

Technical competence in automation and engineering tools (e.g., PLCs, 3D CAD/SolidWorks, instrumentation and sensing technologies) is an advantage.

Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and motivate peers and management.

Ability to guide, direct, and support manufacturing and engineering personnel in both operational and project environments.

Minimum 3–5 years of engineering experience with a focus on process optimization, automation, and/or equipment implementation in a manufacturing environment.

Proven experience managing engineering or technical projects, preferably within the medical devices industry.

Education: Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.

Manufacturing environment and Office environment

Workshop/May include exposure to dust, heat, or cold

Prolonged periods of computer‑based work

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