Job description

Luminex, a DiaSorin Company is seeking dedicated and talented individuals with a proactive and positive ‘can-do’ attitude to join our team. If changing the diagnostic landscape and revolutionizing patient care sounds like something you would like to be a part of, we invite you to apply today! Together, we can help healthcare providers improve patient outcomes, make a difference in fighting the COVID-19 outbreak, and tackle the world’s most pressing health issues. You can learn more about our values, mission, and vision by visiting our website https://www.luminexcorp.com/about-luminex/.

The 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.

What you will do

• Design, implement, and successfully scale-up automated and semi-automated solutions based upon sound engineering principles
• Lead initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limits.
• Collaborate closely with site and global partners to define, develop and deploy automated processing technologies including equipment, single-use disposables and processes
• Develop 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 specifications
• Lead 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 teams
• Support management in business case analysis for new projects which includes inputs such as current Vs. forecast capacity, standard cost analysis, and ROI.
• Develop 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 environment
• Keep abreast of meaningful technical trends and developments and incorporates them into appropriate assignments
• Lead 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 risks
• Perform 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 (for installation qualifications, operational qualifications, performance qualifications and process validations).
• Travel to the vendor sites as needed for equipment development, FAT, or to drive project timeliness.
• Collaborate with the Industrialization team and Maintenance Engineering to troubleshoot manufacturing processes/equipment to resolve production or equipment issues.
• Use CAD to design/review/update tooling and fixtures
• Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
• Support the company’s continuous improvement efforts by supporting assignments in other areas as required.
• Responsible for enforcing all EHS policies in their span of control
• Other duties as assigned.

Education Qualifications

• Bachelor's Degree Engineering degree or related experience preferred or

Experience Qualifications

• 5+ Years Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing, clean room environments required
• 3+ Years Medical products GMP manufacturing experience required
• 3+ Years Successful experience of leading multi-functional teams required
• 3+ Years Experience with development programs
• 3+ Years Experience in a variety of robotic weld applications
• 3+ Years Robot and PLC simulation experience
• 3+ Years Experience with field bus networks, serial communication and Ethernet communication
• 3+ Years Exposure to a wide variety of production machinery, industrial sensors, and equipment.
• 3+ Years Excellent communication skills both written and verbal
• 3+ Years Experience in fast-paced iterative design and manufacturing environments
• 3+ Years Experience solving complex problems with little to no supervision on schedule as an individual or as a member of an integrated team
• 3+ Years Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• 3+ Years Excellent interpersonal, verbal and written communication skills
• 3+ Years Ability to function efficiently and independently in a fast-changing environment
• 3+ Years Self-motivated and willing to accept temporary responsibilities outside of initial job description
• 5+ Years Design, simulate (prototyping), and implement a fully automated controls architecture to build high volume products
• 5+ Years Utilize mechanical automation equipment, robots, PLCs, motion controls, and 3D vision to create entire assembly lines
• 5+ Years Influence the product design in order to simplify and optimize the factory process
• 3+ Years Implement reliable safety systems (ANSI / RIA15.06, OSHA) for safeguarding robots, gantries, conveyors and other high volume manufacturing equipment

Training and Skills

• Ability 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 Certifications

• Lean Six Sigma Certification-IASSC preferred

Standard Working Conditions

• Candidate 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. - Occasionally

Travel Requirements

• 20% Ability to travel domestic

Luminex Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability status of an otherwise qualified individual, citizenship status, membership or application for membership in a uniformed service, or any other protected characteristic or category protected by applicable law.

smogtown13.com is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, smogtown13.com provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, smogtown13.com is the ideal place to find your next job.