Process Engineer II
Job Location:
Austin, TX - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions advancing science to improve patient outcomes worldwide. For more than 50 years we have combined scientific rigor with an entrepreneurial mindset operating with a strong commitment to innovation accountability and results to deliver trusted diagnostic solutions.
As the Diagnostics Specialist Diasorin continuously invests in research technology and people. Guided by our values of operational excellence customer focus and teamwork we empower teams to think boldly act decisively and transform ideas into meaningful impact across one of the industrys broadest specialty diagnostic portfolios.
When you join Diasorin you are not just filling a role. You are helping build what comes next.
- Build What Matters
Take ownership challenge the status quo and contribute directly to solutions that improve patient care worldwide. - Innovate with Agility at a Global Scale
Work in an entrepreneurial environment that enables speed collaboration and global impact. - Grow in a People-Centered Culture
Thrive in a culture that values accountability inclusion and continuous development.
- Lead and manage complex process improvement projects from concept through implementation.
- Identify process inefficiencies and drive measurable improvements with cost quality and throughput outcomes.
- Champion and mentor Lean and Six Sigma principles to improve process yield equipment capacity and factory capability.
- Author and maintain detailed Manufacturing Instructions routings and training documentation for advanced processes.
- Own and execute process validation protocols (IQ/OQ/PQ) with cross functional alignment.
- Analyze Value Stream Maps to identify opportunities for ongoing manufacturing optimization.
- Drive infrastructure expansion and production layout efficiency initiatives.
- Apply advanced Lean tools (e.g. DMAIC Kaizen PDCA) to engineer scalable and sustainable manufacturing processes.
- Design and optimize production cells and material flow to support high-volume and custom manufacturing needs.
- Utilize operational data to recommend and implement performance improving projects.
- Lead root cause investigations of manufacturing or field defects; develop corrective and preventive actions (CAPA).
- Establish and maintain standardized processes across teams and sites.
- Develop and train teams on best practices and SOPs to drive process consistency.
- Ensure compliance with all applicable environmental safety quality and regulatory requirements.
- Use Statistical Process Control (SPC) DOE scripting and dashboards to monitor and reduce process variability.
- Lead creation and updates of FMEAs and Control Plans for key processes.
- Implement human error proofing strategies (Poka Yoke) in complex workflows.
- Optimize line balance cycle time and takt time to support lean operations.
- Develop and present ROI justifications to leadership for proposed capital or process improvements.
- Independently design and conduct Design of Experiments (DOE) for continuous and new product/process validation.
- Collaborate with production teams to resolve process issues and support operator efficiency.
- Lead identification and implementation of automation opportunities.
- Perform hands-on troubleshooting and process refinement as needed on the floor.
- Manage cross functional impacts of procedural engineering and documentation change releases.
- Analyze and implement Engineering Change Orders (ECO) Manufacturer Changes (MCO) and Departmental Changes (DCO).
- Act as liaison between departments to drive collaboration and alignment.
- Escalate complex or systemic issues to leadership proactively.
- Mentor junior engineers and provide technical guidance to cross functional peers.
- Other duties as assigned.
- Bachelors Degree In Industrial Manufacturing Mechanical Engineering or related technical field preferred
- Masters Degree In Engineering or related field preferred
- 5 Years 5 years of experience in process or manufacturing engineering in a regulated industry preferred
- 3 Years 3 years of experience in GMP/FDA regulated or ISO certified environment required
- High proficiency in Microsoft Office Suite (Word Excel Access Visio PowerPoint) (High proficiency)
- Excellent organizational communication and prioritization skills (High proficiency)
- Strong adaptability to fast changing environments and timelines (High proficiency)
- Deep expertise in statistical methods SPC and DOE (High proficiency)
- Advanced troubleshooting and data analysis using scripting databases and dashboards (High proficiency)
- Strong background in time studies industrial engineering and continuous improvement (High proficiency)
- Strong knowledge of cGMP ISO and FDA regulations (Medium proficiency)
- Proven ability to lead projects and work independently (Medium proficiency)
- Demonstrated ability to mentor others and foster cross functional collaboration (Medium proficiency)
- Lean Six Sigma Black Belt preferred
- ASQ Certified Quality Engineer. preferred
- Standard manufacturing and office environment - Constantly
- 10% Potential travel for training shadowing leading events
Diasorin is committed to building a workplace where people feel empowered to contribute ideas take ownership and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability protected veteran status or any other characteristic protected by applicable law.
This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures candidate rights and employment conditions may apply based on local jurisdiction.
Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required please contact .
Recruitment Fraud Notice
Diasorin never requests payment financial information or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @ email address. If you have questions about the legitimacy of a recruitment communication please contact for verification.
Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.
Required Experience:
IC
About Company
Luminex Licensed Technology: Diasorin provides innovative xMAP® Technology solutions for fast, reliable answers in research, impacting daily patient health outcomes.
