Senior Manufacturing Engineer

onehealthineers; Austin (TX); On-site; AUD 155,000 - 212,000; Full time

Job summary

onehealthineers is seeking a Senior Manufacturing Engineer to lead major engineering projects supporting sustaining operations and new product introductions. You will define manufacturing requirements, develop processes, and ensure DFMs are applied across products.

Role involves partnering with design teams, optimizing manufacturing methods, and mentoring junior engineers while driving lean initiatives and process improvements in a regulated environment.

Qualifications

• Master's degree in mechanical engineering, industrial engineering, or related field; 3 years of experience in manufacturing/engineering roles.
• Experience leading engineering projects for sustaining operations and new product introductions.
• Ability to define manufacturing requirements, cost estimates, and tooling needs.

Responsibilities

• Lead significant engineering projects supporting sustaining operations and new product introductions.
• Develop and maintain manufacturing methods, process flows, and work instructions.
• Define manufacturing requirements for components and finished products.
• Lead process development, optimization, and automation initiatives.
• Interface with design to ensure manufacturability and DFMs.
• Mentor junior engineers and manage cross-functional teams.

Skills

Manufacturing engineering

Process development

DFM (design for manufacturability)

CAPA

Data analysis

Statistical methods

Project management

Education

Master's degree in mechanical engineering or industrial engineering

Tools

CAD software

MES

SAP

Job description

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: Must have experience and/or academic training with each of the following:

• 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 val