Senior Manufacturing Engineer

ERServices seeks a Senior Manufacturing Engineer in Bettlach, CH, to lead process validation, optimization, and continuous improvement within a regulated medical device environment.

ERServices is looking for a Senior Manufacturing Engineer to serve as a Subject Matter Expert for production processes. The role focuses on enhancing operational efficiency, minimizing scrap, and maintaining product quality through data-driven analysis and structured methodologies within a regulated medical device setting.

Responsibilities

• Drive continuous improvement projects aimed at boosting productivity, quality, and cost-effectiveness in a medical device manufacturing setting.
• Examine production data to pinpoint trends and root causes, applying Lean Manufacturing, Six Sigma, and statistical analysis to optimize processes and reduce waste.
• Serve as the primary technical resource for assigned manufacturing operations, ensuring consistency, quality, and efficiency.
• Create and carry out process validation activities, including IQ/OQ/PQ protocols and related documentation.
• Offer daily technical and operational support to production teams and cross-functional groups, addressing manufacturing issues and implementing corrective actions.
• Partner with production, quality, maintenance, and engineering departments to enhance manufacturing performance and process reliability.
• Assist with new product introductions, process transfers, equipment qualifications, risk assessments, and FMEA activities, while supporting audits and ensuring adherence to regulatory standards.
• Guarantee that all manufacturing processes meet GMP and GDP compliance requirements.

Requirements

• Bachelor’s or Master’s degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• At least five years of experience in medical device manufacturing or other highly regulated sectors.
• Proven expertise in manufacturing engineering, process optimization, and validation methodologies.
• Practical experience with process validation, equipment qualification, and manufacturing process controls.
• Solid understanding of GMP, GDP, ISO 13485, and regulated manufacturing environments.
• Proficiency in statistical analysis tools and structured problem-solving methodologies.
• Strong analytical, communication, and project management capabilities.

Nice to have

• Lean Six Sigma Green Belt certification is preferred.
• Experience with ERP/MES systems and manufacturing data reporting tools is advantageous.
• Familiarity with Power BI and data visualization/reporting tools is a plus.

What the company offers

• A dynamic and varied role within a global organization with strong local roots.
• Competitive employment conditions with long-term career prospects.
• Significant autonomy and personal responsibility in daily tasks.
• An environment that encourages creative thinking and continuous learning.
• Performance bonuses, additional vacation days, and various other benefits.

About the company

ERServices operates as part of a global network that combines international reach with local expertise to provide scalable and customized solutions. The organization is dedicated to building sustainable processes that reduce environmental impact and support vibrant, diverse communities worldwide.

• Global reach combined with local expertise for tailored solutions.
• Commitment to sustainable processes and minimizing environmental impact.
• Fostering vibrant and diverse communities globally.

How to apply

Documents to submit:

• complete application documents