Manufacturing Engineer - Level I

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 weve 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 thats 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 youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were 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 thats 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 Engineering Level 1 will be responsible for directingtechnical support for Instruments and Consumable Manufacturing operations in ISO 13485 and FDA regulated medical device setting. Representing Operations in design teams for new and on market product design and development design transfer and market phases. Facilitating in the definition of project tasks establishing timelines and fulfilling responsibilities for product design transfer and related process engineering. Collaborating on the development and assuming full ownership at Production release of material specifications/drawings manufacturing processes repair/refurb processes fixtures test methods analysis tools and related acceptance criteria for new or on market product. Leading and assisting in product supplier and process sustaining engineering initiatives to scale manufacturing throughput and improve quality compliance safety yields efficiency reliability and cost. 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.

Key Duties and 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.
• Other duties as assigned.

Education Experience and Qualifications

• Bachelors Degree Bachelors of Science in the field of Mechanical Electrical Industrial Bio-medical or Biomechanical Engineering. required

• 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 preferred
• Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities preferred

• 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

Standard Physical Demands

• Writing - Frequently
• Typing - Frequently
• Bending - Occasionally
• Color vision on the job - Constantly
• Lifting 20-50 lbs - Frequently

Standard Working Conditions

• Must work onsite at Luminex office - Constantly
• Work is typically performed in an office environment. - Frequently
• Possible exposure to mechanical biological and chemical hazards. - Frequently
• Possible exposure to Chemicals Lasers Excessive Noise etc. - Frequently
• Work in manufacturing setting which may include BioSafety Level 2 areas; work may be performed in fume hood clean hood biosafety cabinet and/or ISO Class 7 cleanroom with specialized gowning and safety requirements - Frequently
• Work in walk-in refrigerators and freezers that encompass conditions down to -20C - Frequently
• Work situations include dealing with people; working alone; making judgments and decisions; and directing controlling or planning the activity of others - Frequently
• Frequent use of personal computer and office equipment. - Frequently
• Frequent use of data and word processing programs. - Frequently

Travel Requirements

• 10% Travel may be required at least 10% of the time

What We Offer

Salary Range

The hourly range for this position is $33.31 - $56.63. 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 wages 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 or 1- 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.