Process Development Engineer- Level II

Published on: Aug 5, 2025

Country: United States

Location: Chicago

Company: Luminex Corporation

Job Category: Operations

Employment type: Regular Full Time

Req ID: 7090

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!

A Brief Overview

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

What we offer

Salary Range

The salary range for this position is $78,767-120,000.00 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive 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.

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.