Process Development Engineer- Level II

Process Development Engineer - Level IIPublished on: Sep 3, 2025Country: United StatesLocation: ChicagoCompany: Luminex CorporationJob Category: OperationsEmployment type: Regular Full TimeDiasorin OverviewDiasorin 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 have 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 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 ScopeThe Process Development Engineer Level II is responsible to develop automated processes that support the mass production of new and/or existing products. This role will create automated systems for mass production that integrate processes such as cutting/heat sealing, lamination, pick-n-place systems, assembly, ultrasonic welding, precision filling, capping, label placement and packaging.Key Responsibilities and Duties:Design, implement, and successfully scale-up automated and semi-automated solutions based upon sound engineering principlesLead initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limitsCollaborate closely with site and global partners to define, develop and deploy automated processing technologies including equipment, single-use disposables and processesDevelop user requirements based on process, quality and fitness for use in a GMP manufacturing environment. Work with vendors, suppliers, and internal partners to translate specific requirements into functional and design specificationsLead hands-on activities that support process development and process characterization, including drafting procedures, execution of prototype studies, authoring technical reports, and participating on multi-functional risk assessment teamsSupport management in business case analysis for new projects which includes inputs such as current Vs. forecast capacity, standard cost analysis, and ROIDevelop automated manufacturing processes by sourcing relevant technology and/or collaborating with automation vendors to design customized medical device manufacturing equipment to improve safety, quality, efficiency and cost within the manufacturing environmentKeep abreast of meaningful technical trends and developments and incorporated them into appropriate assignmentsLead the project management of automation development by using visual project management tools (MS Project, critical path analysis, etc.). Define, manage, and communicate project timelines and risksPerform Design for Manufacturing DFM, Design of Experiments DOE and design/process Failure Mode and Effects Analysis (DFMEA/PFMEA)Collaborate with the Industrialization team for the development of validation protocols as well as its execution and reporting (installation qualifications, operational qualifications, performance qualifications and process validations)Travel to the vendor sites as needed for equipment development, FAT, or to drive project timelinessCollaborate with the Industrialization team and Maintenance Engineering to troubleshoot manufacturing processes/equipment to resolve production or equipment issuesUse CAD to design/review/update tooling and fixturesResponsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policiesSupport the company/'s continuous improvement efforts by supporting assignments in other areas as requiredResponsible for enforcing all EHS policies in their span of controlOther duties as assignedEducation, Experience, and QualificationsBachelor/'s Degree Engineering degree or related experience preferred or5+ Years Demonstrated knowledge of pharmaceutical cGMP, biotechnology products, aseptic processing, clean room environments required3+ Years Medical products GMP manufacturing experience required3+ Years Successful experience of leading multi-functional teams required3+ Years Experience with development programs3+ Years Experience in a variety of robotic weld applications3+ Years Robot and PLC simulation experience3+ Years Experience with field bus networks, serial communication and Ethernet communication3+ Years Exposure to a wide variety of production machinery, industrial sensors, and equipment3+ Years Excellent communication skills both written and verbal3+ Years Experience in fast-paced iterative design and manufacturing environments3+ Years Experience solving complex problems with little to no supervision on schedule as an individual or as a member of an integrated team3+ Years Ability to think critically, and demonstrated troubleshooting and problem-solving skills3+ Years Excellent interpersonal, verbal and written communication skills3+ Years Ability to function efficiently and independently in a fast-changing environment3+ Years Self-motivated and willing to accept temporary responsibilities outside of initial job description5+ Years Design, simulate (prototyping), and implement a fully automated controls architecture to build high volume products5+ Years Utilize mechanical automation equipment, robots, PLCs, motion controls, and 3D vision to create entire assembly lines5+ Years Influence the product design in order to simplify and optimize the factory process3+ Years Implement reliable safety systems (ANSI / RIA15.06, OSHA) for safeguarding robots, gantries, conveyors and other high volume manufacturing equipmentTraining and SkillsAbility to handle and reason through complex information, define problems, collect data, establish facts, and draw objective conclusions. (High proficiency)Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables. (High proficiency)Able to leverage project management & technical experience to foresight potential problems and develop contingency plans to ensure swift recovery in case of adversity. (High proficiency)Must be able to deconstruct a problem effectively in order to find the best and fastest solution. (High proficiency)Must be able to reason and communicate clearly under pressure. Fast learner and adaptable to medical device processes and regulations. (High proficiency)Licenses and CertificationsLean Six Sigma Certification - IASSC preferredStandard Working ConditionsCandidate must be able to support occasional extended work hours to lead equipment troubleshooting/repairs when needed. Weekend or after-hours on-call support to ensure equipment is operational to support production plans. - OccasionallyTravel Requirements20% Ability to travel domesticWhat we offerSalary Range The salary range for this position is $80,000 - 120,000 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, education, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a comprehensive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.Equal Opportunity and ComplianceDiasorin 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 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 require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at 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. #J-18808-Ljbffr

Created: 2025-09-17