Senior Manufacturing Engineer

DiaSorin
United States, Texas, Austin
May 17, 2025
Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world. Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist." Why Join Diasorin? Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world. Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry. Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive. Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward. Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact! Job Scope The Manufacturing Engineering team is responsible for the innovation, industrialization, and sustainment of advanced production systems. The Senior Manufacturing Engineer will serve as a technical leader with opportunities to lead a small team of engineers, while developing and implementing manufacturing solutions that support operational excellence. This role demands a hands-on leader with an electrical engineering background and strong expertise in electromechanical systems troubleshooting. The engineer will collaborate cross-functionally to deliver practical solutions to technical challenges, scale up processes from R&D, and ensure compliance with applicable regulatory requirements. Key Duties and Responsibilities Lead and mentor a small teamof engineers and technicians to drive project execution and daily manufacturing support activities. Provide hands-on troubleshooting of electromechanical equipment and systems to resolve technical issues and minimize downtime. Create and execute protocols (IQ/OQ/PQ) and author validation reports for equipment and process qualification. Create and implement Engineering Change Orders (ECOs) to ensure controlled updates to processes, equipment, and documentation. Manage and lead continuous improvement initiatives focused on increasing efficiency, improving product consistency, and reducing waste. Develop new processes, tooling, and production layouts to support product design and scalability. Write and maintain technical documentation, including SOPs, URS, engineering reports, and change records. Analyze capacity, equipment efficiency, and labor utilization to optimize manufacturing performance. Collaborate with R&D to transfer new products into production, ensuring design for manufacturability. Support investigations related to CAPAs, NCRs, and quality issues in partnership with Production and Quality teams. Ensure all activities comply with FDA, ISO13485, GAMP, and GMP standards. Develop and manage detailed project plans using project management methodologies and tools. Education, Experience, and Qualifications Bachelor's Degree in Electrical Engineering or a related discipline such as Mechanical or Industrial Engineering required. Minimum 5 years of experience in a regulated industry (IVD, medical device, or pharmaceutical) required. Proven experience in leading technical teams or mentoring junior engineers Strong background in equipment and process validation (IQ/OQ/PQ) and process automation. Hands-on experience with troubleshooting and supporting electromechanical systems. Solid understanding of statistical process control, quality systems, and root cause analysis. Proficiency in LEAN manufacturing, DOE, FMEA, and continuous improvement techniques. Strong technical writing and verbal communication skills. Proficient in Microsoft Office, SolidWorks, and Minitab Ability to solve complex problems and communicate technical information effectively. What We Offer Receive a competitive salary and benefits package as you grow your career at Diasorin. Join our team and discover how your work can impact the lives of people all over the world. 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, or protected veteran status, and will not be discriminated against on the basis of disability. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation. The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations. Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations. This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.