Full Job Description
Job Scope
Evaluate and optimize Manufacturing processes to improve product consistency, quality and to increase productivity. Write and perform validations and validation reports for production equipment as necessary. Support all applicable regulations including but not limited to FDA, ISO requirements.
Job Responsibilities and Duties
- Work with Production and Technical Support personnel to identify, isolate and correct technical challenges for improving product reproducibility.
- Improve Production processes to reduce production costs and decrease scrap.
- Research and purchase new manufacturing technology including automated equipment to improve production using project management tools.
- Implement the transition of new manufacturing technology to ensure production continues successfully. This includes leading the validation and PCR effort as well as any training necessary.
- Coordinate and supervise required validations of processes and equipment.
- Improve and implement new processes.
- Participate on cross-functional core teams for new products to represent Operations and Manufacturing Engineering.
- Participate to support both internal and external audits.
- Maintain and increase work flow.
- Interact with all required departments to assist with project completion.
- Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
- May delegate and coordinate workload for technician group as needed. Responsible for enforcing all EHS policies in their span of control.
- Perform other duties as assigned.
Education, Experience and Qualifications
- Bachelor's Degree in an engineering discipline such as Mechanical, Electrical or Industrial Engineering, Required
- 2+ Years with BS - related experience in IVD, medical, pharmaceutical, or other related industry, Required Or
- 1+ Years with MS- related experience in IVD, medical, pharmaceutical, or other related industry, Required
- ASQ Certified Quality Engineer, Preferred.
- Preferred understanding of statistical quality control, statistical process control, Corrective Action Process, and their application manufacturing as a problem identification and resolution tool
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Ability to write reports, business correspondence, and procedure manuals.
- Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public
- Ability to apply advanced mathematical concepts from calculus and statistics.
- Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
- Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
What we offer
The hiring range for this position is $97,300 - $131,700 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 committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.