Manufacturing Engineer - Level II (Controls)

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 Engineer, Level II (Controls) will be responsible for: designing, developing, and implementing automated control systems to enhance the efficiency and reliability of our Instruments Manufacturing operations. This role requires a strong technical background, attention to detail, and a deep understanding of automation and control systems in a regulated environment (ISO 13485 and FDA regulated medical device setting). Facilitating in the definition of project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering. Facilitating the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints. Task-specific and change control training of Manufacturing personnel.

What you will do

• Design, develop, and implement control systems for automation in the manufacturing of medical devices.
• Develop and program PLCs (Programmable Logic Controllers) and/or HMI (Human-Machine Interface) systems.
• Collaborate with R&D, Quality Assurance, and Manufacturing teams to identify automation needs and develop solutions.
• Troubleshoot and resolve control system issues to ensure optimal performance and reliability.
• Ensure compliance with regulatory standards (e.g., FDA, ISO 13485) in the design and implementation of control systems.
• Develop and maintain detailed documentation of control systems, including schematics, wiring diagrams, and software code.
• Conduct risk assessments and participate in Failure Modes and Effects Analysis (FMEA) to identify and mitigate potential issues.
• Assume full ownership of design, specification development and selection of new production equipment, such as, test fixtures, manufacturing aids, and automation equipment; includes scale-up of existing processes and development of new processes

• Stay updated on industry trends, standards, and technological advancements to continuously improve automation processes.
• Lead and assist in engineering change control and document change control activities; participate in change control reviews.
• Ensure effective training of Manufacturing and Quality Control personnel for transfer of new test fixtures, manufacturing aids, and automation equipment
• Assist the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
• Lead and assist in design input and implementation oversight of infrastructure improvement projects
• Lead and assist external technology transfers and contract manufacturing transfers.
• Ensure personal compliance and promote operational compliance with the Quality System and other regulations.
• Ensure compliance to NFPA, OSHA, lock-out, and other applicable safety standards.
• Other duties as assigned.

Education and Experience Qualifications

• Bachelor’s degree in relevant engineering discipline; electrical, automation, or process control preferred.
• Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Automation Engineering, or a related field.
• 3-5 years of experience in control/automation engineering, preferably in the medical device or a similar regulated industry.
• Proficiency in programming and configuring HMI systems.
• Data analytics experience (SQL, Tableau, Power BI)
• Experience programming in Python (Scripting and Automation)
• Advanced user of SolidWorks
• Excellent problem-solving skills and attention to detail.
• Strong communication and teamwork skills.
• Experience with SCADA systems and industrial networks
• Equipment integration experience using IIoT, OPC and/or PTC Kepware
• Ability to debug electrical, mechanical & micro fluidics components
• Expertise in developing requirement for sensors and actuators.

Training and Skills

• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
• Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
• Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments
• Mathematics and statistics aptitude.
• Data analysis and technical writing aptitude.
• Excellent oral and written communication skills.
• Geometric Dimensioning & Tolerancing
• CAD/design/engineering exposure
• PLC programming
• Proficient in Microsoft Word, Excel, and PowerPoint programs.
• Highly organized with proven time management and prioritization skills
• Ability to work independently and with minimal supervision
• Ability to handle the pressure of meeting tight deadlines

Preferred Skills:

• Familiarity with LabVIEW, MATLAB, or other automation software.
• Experience with robotics and motion control systems.
• Certification in Quality Assurance or related fields (e.g., ASQ, Six Sigma)

Travel Requirements

• 10% Travel may be required up to 10% of the time

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.