Manufacturing Engineer - BioFire Diagnostics, LLC.

The manufacturing engineer is a key contributor for the sustainment and performance of VITEK REVEAL sensors production. This position will work with cross-functional team to support all aspect of the consumable manufacturing process and continuous improvement initiatives. This role is an onsite position and requires hands on with manufacturing equipment and processes. Experience with medical device assembly and manufacturing in an FDA regulated environment is required.





PRIMARY DUTIES:



+ Accountable for 1st level of engineering escalation during production to ensure production continuity and document failure analysis and corrective actions per GMP requirements.


+ Collaborate with senior engineers to design and perform characterization studies & DOE’s to optimize existing manufacturing equipment and assembly processes.


+ Support production scale-up activities and new manufacturing technology projects.


+ Coordinate with other departments to execute continuous improvement/engineering studies under minimum supervision.


+ Perform troubleshooting and routine maintenance of manual and automated manufacturing processes with assistance of senior engineers if needed.


+ Perform failure investigations and root cause analyses of NCR and corrective/preventive action (CAPA).


+ Contribute to solving manufacturing engineering problems to improve safety and efficiency.


+ Collaborate cross-functionally with senior engineers to develop protocols and execute FAT, SAT, Equipment IOPQ, and process validation activities.


+ Create clear and concise documentations including operating procedures, engineering studies and reports.


+ Execute validation of new equipment and processes consistent with the quality management system and GMP requirements.


+ Provide the hands-on training to technicians and manufacturing associates to improve knowledge and response times.


+ Comply to GMP and GDP guidelines and QMS documentation requirement.


+ Other duties or support assigned by the manager.






QUALIFICATIONS:



+ Bachelor of Science in Mechanical Engineering or Biomedical Engineering with 1 year of relevant experience or equivalent combination of education and experience to perform at this level, and at least one year of working experience in a GMP, FDA/ISO 13485 medical device regulated environment.


+ Previous experience with process and equipment validations, calibration and PM in a regulated manufacturing environment (ISO 13485 medical device / FDA)


+ Previous experience with hands-on troubleshooting production equipment


+ Must have the ability to succeed in a fast-paced environment with proven ability to be flexible and adaptable within a changing dynamic environment and ambiguous scope.


+ Strong oral and written communication, and interpersonal skills.


+ Ability to read and understand mechanical drawings.


+ ⁠Experience with 3D design packages (Solidworks, Inventor, Pro E) and engineering drawings interpretation (GD&T)


+ Must have strong computer skills, including all MS Office applications, learning portal and training application


+ Experience with data analysis and statistical analysis software (JMP, MiniTab or similar) is a plus





The estimated salary range for this role based in California is between $90,000 and $110,000 salary. This role is eligible to receive a variable annual bonus based on company, team, and individual performance per bioMerieux’s bonus program. This range may differ from ranges offered for similar positions elsewhere in the country given differences in cost of living. Actual compensation within this range is determined based on the successful candidate’s experience and will be presented in writing at the time of the offer.


In addition, bioMérieux offers a competitive Total Rewards package that may include:



+ A choice of medical (including prescription), dental, and vision plans providing nationwide coverage and telemedicine options


+ Company-Provided Life and Accidental Death Insurance


+ Short and Long-Term Disability Insurance


+ Retirement Plan including a generous non-discretionary employer contribution and employer match.


+ Adoption Assistance


+ Wellness Programs


+ Employee Assistance Program


+ Commuter Benefits


+ Various voluntary benefit offerings


+ Discount programs


+ Parental leaves