Manufacturing Engineer - Level I

Diasorin•Austin, TX

2d•Onsite

About The Position

The Manufacturing Engineering, Level 1 will be responsible for direct technical 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.

Requirements

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

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.