Senior Manufacturing Engineer

Siemens Healthineers; Schönhausen; Vor Ort; EUR 90.000 - 125.000; Vollzeit

Zusammenfassung

Siemens Healthineers seeks a Senior Manufacturing Engineer to lead major projects in sustaining operations and new product introductions. You will develop manufacturing methods, define requirements, estimate costs, and mentor staff while ensuring regulatory compliance and CAPA handling.

Responsibilities include process development, automation, capacity planning, cross-functional coordination, and data-driven problem solving to optimize manufacturing and reduce waste.

Qualifikationen

• Master’s degree in mechanical engineering, industrial engineering, or a related field (or foreign equivalent).
• Three (3) years of experience in the job offered, or as Design and Manufacturing Engineer, Project Engineer, or a related occupation.

Aufgaben

• Lead and manage significant engineering projects supporting sustaining operations and new product introductions.
• Develop, implement, and maintain manufacturing methods, process flows, work instructions, and production documentation.
• Define manufacturing requirements for components, subassemblies, and finished products.
• Estimate manufacturing costs, establish time standards, and recommend tooling and equipment requirements.
• Lead process development, optimization, and automation initiatives.
• Support capacity planning, line balancing, and scale-up activities.
• Serve as SME for manufacturing processes, equipment, and materials.
• Interface with Design Engineering to ensure manufacturability and alignment with product requirements.
• Lead design reviews and ensure design-for-manufacturability (DFM) principles are applied.
• Analyze test data to define process limits, specifications, and control strategies.
• Troubleshoot complex manufacturing issues using data-driven root cause analysis.
• Mentor and provide technical guidance to junior engineers and technical staff.
• Lead large-scale process improvement and new product introduction projects.
• Coordinate cross-functional teams to drive execution and resolve issues.
• Manage project timelines, deliverables, and technical documentation.
• Support capital equipment planning, justification, and onboarding.
• Ensure compliance with FDA, ISO, GMP, GLP, and GDP requirements.
• Lead or support deviations, CAPAs, and nonconformance resolution.
• Participate in internal and external audits.
• Ensure documentation meets regulatory and company standards.
• Perform statistical analysis and process capability studies.
• Develop control charts and lead continuous improvement initiatives.
• Utilize MES, SAP, and other enterprise systems for manufacturing and quality tracking.
• Support implementation and optimization of manufacturing systems and automation.
• Analyze BOMs, routings, and cost drivers to improve efficiency and reduce waste.
• Author and review manufacturing instructions, validation protocols, SOPs, ECNs, and reports.
• Create and deliver technical presentations, training, and knowledge transfer sessions.
• Support audit readiness and regulatory inspections.

Ausbildung

Master's degree in mechanical engineering, industrial engineering, or related field

Jobbeschreibung

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Job Title : Senior Manufacturing Engineer

Job Site: 9825 Spectrum Drive, Building 2, Suite 250, Austin, TX 78717

Minimum Requirements

A master’s degree in mechanical engineering, industrial engineering, or a related field (or foreign equivalent) and three (3) years of experience in the job offered, or as Design and Manufacturing Engineer, Project Engineer, or a related occupation.

Job Duties

• Lead and manage significant engineering projects supporting sustaining operations and new product introductions.

• Develop, implement, and maintain manufacturing methods, process flows, work instructions, and production documentation.

• Define manufacturing requirements for components, subassemblies, and finished products.

• Estimate manufacturing costs, establish time standards, and recommend tooling and equipment requirements.

• Lead process development, optimization, and automation initiatives.

• Support capacity planning, line balancing, and scale-up activities.

• Serve as SME for manufacturing processes, equipment, and materials.

• Interface with Design Engineering to ensure manufacturability and alignment with product requirements.

• Lead design reviews and ensure design-for-manufacturability (DFM) principles are applied.

• Analyze test data to define process limits, specifications, and control strategies.

• Troubleshoot complex manufacturing issues using data-driven root cause analysis.

• Mentor and provide technical guidance to junior engineers and technical staff.

• Lead large-scale process improvement and new product introduction projects.

• Coordinate cross-functional teams to drive execution and resolve issues.

• Manage project timelines, deliverables, and technical documentation.

• Support capital equipment planning, justification, and onboarding.

• Ensure compliance with FDA, ISO, GMP, GLP, and GDP requirements.

• Lead or support:

  • Process, equipment, cleaning, and software validations
  • Test method development and validation
  • Risk assessments (FMEA, hazard analysis)

• Own or support deviation investigations, CAPAs, and nonconformance resolution.

• Participate in internal and external audits.

• Ensure documentation meets regulatory and company standards.

• Perform statistical analysis and process capability studies.

• Develop control charts and lead continuous improvement initiatives.

• Utilize MES, SAP, and other enterprise systems for manufacturing and quality tracking.

• Support implementation and optimization of manufacturing systems and automation.

• Analyze BOMs, routings, and cost drivers to improve efficiency and reduce waste.

• Author and review:

  • Manufacturing Instructions
  • Validation protocols and reports
  • SOPs and work instructions
  • Engineering Change Notices (ECNs)
  • Risk assessments and technical reports

• Create and deliver technical presentations, training, and knowledge transfer sessions.

• Support audit readiness and regulatory inspections.

Special Requirements

• Developing innovative product concepts and create detailed designs using CAD software, ensuring functionality, performance, and alignment with customer needs.
• Building and testing prototypes, conduct simulations, and perform design validation to ensure the product meets technical and regulatory standards.
• Identifying opportunities for design optimization, cost reduction, and process improvements while incorporating new technologies and materials.
• Managing project timelines, budgets, and technical documentation, ensuring smooth product development from initial concept to minimal viable product.
• Designing and optimizing manufacturing processes and workflows to ensure efficient and cost-effective production. Identify opportunities for automation and implement new technologies or equipment to improve manufacturing efficiencies (electro-mechanical assembly and chemistry-based particle synthesis & processing)
• Developing production plans and schedules, considering factors such as resource allocation, capacity planning, and lead times. Working closely with production teams to ensure smooth execution of manufacturing processes.
• Analyzing manufacturing costs, identifying areas for cost reduction, and propose design or process modifications to optimize production efficiency without compromising quality.
• Continuously monitoring and evaluating manufacturing processes to identify opportunities for improvement. Implement lean manufacturing principles and methodologies to streamline operations and reduce waste.
• Delivering projects to manufacturing in support of the plant’s safety, quality, delivery, and cost goals.
• Executing equipment design, equipment validations, and vendor management.
• Applying strong project management skills including timeline tracking, developing cost/capital estimates, project budget tracking, planning, and coordinating resources, proficient technical writing/documentation capabilities,
• Good Manufacturing Practices (GMP) standards
• Project Management
• Concept development including prototyping and new product testing.
• Manufacturing test methods
• Change Owner/Management
• Prototyping & Testing
• Design for Manufacturability (DFM) & Design for Assembly (DFA)
• Innovative and creative product design solutions
• Advanced manufacturing techniques & manufacturing process development
• New Product design and analysis
• Continuous improvement
• Complex large scale equipment manufacturing
• Machined parts and electromechanical assemblies
• Installation Qualification, Operational Qualification, Process Qualification (IQ/OQ/PQ)
• Statistical Analysis
• Systematic Problem Solving & analytical skills
• Computer Aided Drafting (CAD)
• Problem solving and Corrective Action and Preventative Actions (CAPA)
• Change Management, equipment design reviews, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), capital request and test reports
• Cost Analysis and Optimization

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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“A successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions.”

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