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About the Role

The Manufacturing Engineering, Level 1 will provide direct technical support for Instruments and Consumable Manufacturing operations in an ISO 13485 and FDA regulated medical device setting. This role represents Operations in design teams for new and on-market product development, design transfer, and market phases, facilitating task definition, timeline establishment, and process engineering responsibilities.

Responsibilities

Represent Operations in design teams; fulfill design transfer responsibilities for new and on market product development, validation, and market release phases.
Assume full ownership of sustaining engineering support for on-market products.
Lead or assist in sustaining engineering initiatives to support obsolescence management.
Lead or assist in product, supplier, and process sustaining engineering initiatives to improve quality, compliance, safety, efficiency, reliability, cost, and scale throughput.
Provide technical support for supplier issues.
Participate and drive development and implementation of process automation strategies and solutions.
Lead and assist in engineering change control and document change control activities; participate in change control reviews.
Collaborate with R&D on development and assume full design transfer ownership for Production and Market release of material specifications/drawings, manufacturing processes, repair/refurb processes, fixtures, test methods, analysis tools, work instructions and related acceptance criteria for new or on market product.
Establish and maintain standard architecture of BOMs and routings.
Collaborate with R&D on OQ process validation planning and execution. Assume full ownership of PQ process validation planning, execution, and reporting.
Assume full ownership of equipment, test fixture, test method, analysis tool validation planning, execution, and reporting; collaborate with R&D as required.
Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes.
Assist the investigation and resolution of findings impacting the organization identified through audits, non-conformances, corrective/preventative actions, or customer complaint escalation.
Participate in or conduct applicable departmental, interdepartmental and intra-departmental training.
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.

Requirements

Thorough knowledge of ISO 13485 and FDA Quality System requirements.
Knowledge of Enterprise Resource Planning, including applied knowledge of engineering functionality.
Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control.
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.
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.

Skills

Process improvement
Sustaining engineering
Six Sigma
Lean Manufacturing
Statistical design of experiments
Data analysis
Technical writing
Microsoft Word
Microsoft Excel
Microsoft PowerPoint

Location

Office environment

Work Type

Full-time

Experience Level

5+ Years Experience and technical leadership supporting process improvement and sustaining engineering in a ISO 13485 and/or FDA regulated Life Sciences, Medical Device, or Medical Technology industry.
1+ Years Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities

Education Level

Bachelor's Degree Bachelors of Science in the field of Mechanical, Electrical, Industrial, Bio-medical, or Biomechanical Engineering.

Benefits

Competitive salary and benefits package

About the Company

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
Diasorin continuously invests in research, technology, and people.
Guided by our values of operational excellence, customer focus, and teamwork, Diasorin empowers teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.
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.

Equal Opportunity

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, disability, protected veteran status, or any other characteristic protected by applicable law.