Manufacturing Engineer

We are seeking a manufacturing engineer or technologist with the primary responsibility of developing manufacturing processes for our sequencing reagents.  The development activities will include set up of pilot manufacturing suite, scale-up of R&D processes, management of testing procedures and transfer of knowledge.  The ideal candidate must have a strong desire to work in an exciting, fast-paced environment that values innovative ideas.  Must be based in Houston.

Responsibilities:

  • Specify raw material bill of materials and drive onboarding of those materials along with proposed incoming analytical testing
  • Make suggestions on improvements based on recent technical knowledge and experience.
  • Organize data and preparing appropriate documentation, including presentation materials, for assigned projects
  • Ensure availability of all materials and consumables
  • Support design and qualification of manufacturing facility and equipment
  • Actively participate in technology knowledge transfer
  • Collaborate cross-functionally with R&D, Chemistry, Hardware and Quality to identify process improvements and support product/process changes.
  • Author and support adherence to manufacturing work instructions, SOPs, policies and procedures, including any department specific requirements in addition to accurate DHR and quality records.
  • Support validation projects from initial planning stages and throughout execution, review, and completion/approval of final reports.
  • Assist with determination of root cause, impact, and resolution of problems impacting production.
  • Assist with documentation and resolution of deviations that occur in the support of the Manufacturing process.
  • Analyze manufacturing data to identify opportunities to improve QC metrics and assembly techniques
  • Support vendor escalations for consumables, support Quality for vendor CAPA & SCAR
  • Provide in-house maintenance and calibration support for manufacturing equipment
  • Support new equipment with IQ/OQ

Desired Experience:

  • 3-5 years’ experience within an operations or manufacturing environment with understanding of medical device industry.
  • Degree in engineering, life sciences or similar
  • Application of manufacturing processes to a regulated environment (i.e. ISO13485, cGMP); knowledge of LEAN/SixSigma highly desired
  • Ability to provide guidance and training in the practical and risk based application of regulations and standards.
  • Possess excellent analytical and problem solving skills coupled with experience in project management
  • Excellent communication skills with ability to work in a cooperative, interactive group setting.
  • Highly organized with ability to keep track of multiple projects simultaneously.
  • Computer skills including Microsoft suite required, statistical and regulatory a plus.
  • Ability to solve routine engineering/process improvement tasks and manage small projects with minimal assistance.
  • Ability to discuss normally encountered technical or project management issues, both verbally and in written form.

Interested applicants should forward their cover letter and CV to hr@lasergen.com.