MicroVention, Inc

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Principal Engineer/Staff Engineer, R&D Process Development

at MicroVention, Inc

Posted: 7/2/2019
Job Reference #: 437567
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Job Description

Title
Principal Engineer/Staff Engineer, R&D Process

Job Description
Direct hands-on technical leadership to conceptualize, develop and optimize processes for prototyping and manufacturing new medical devices, combination devices, and line extensions. Provides hands-on support and project management to characterize processes and implement innovative fixtures, equipment and automation to optimize processes. Works closely with R&D, Manufacturing, Quality, Tooling, and Regulatory teams internally and outside vendors and consultants.  Job duties:
  • Initiates process conceptualization and development on prototype scale.  Supports and manages scale up activity through pilot and transfer to manufacturing. 
  • Implements fixtures, equipment and automation to create optimum manufacturing processes and product testing. 
  • Formulates hypothesis, collects and analyzes data and presents solutions to R&D and manufacturing teams. 
  • Supports validation and verification of product, equipment and processes.
  • Spearheads root cause analysis investigations related to product and process failures.
  • Supports builds for new products in prototype, pilot and production setting, including training of operators, technicians manufacturing engineers. 
  • Documents process and product development and investigations per Quality Systems.
  • Identifies process issues and executes improvements.
  • Works with minimal supervision.
  • Management and support of technicians and engineers as needed.
  • Performs other duties and responsibilities as assigned.


Auto req ID
7177BR

Location
Aliso Viejo, California, USA

Department Name
800-California Interventional Systems (CAIS)

Qualifications
  1. Bachelor’s Degree in Mechanical, Chemical, and/or Material Science Engineering.
  2. A minimum of 10 (ten) years of hands-on medical device industry experience, the majority in process development.
  3. Strong technical and hands on skills and judgment related to medical device product and process development.
  4. Experience in working on products from bench scale to manufacturing and troubleshooting.
  5. Proven ability to design, execute and analyze processes using designs/experiments/statistics.
  6. Ability to read and prepare technical documentation, including manufacturing and R&D procedures, specs and engineering drawings.
  7. Expert proficiency with CAD and/or SolidWorks.
Desired Qualifications
  1. Ability to effectively manage internal and external customer relationships as well as leading different key players on achieving a goal.
  2. Expert proficiency with MS Word, Excel, and PowerPoint.
  3. Ability to work closely and effectively with multiple departments and associates.
  4. Ability to prioritize and meet deadlines in a timely manner.


External-Facing Title
Principal Engineer/Staff Engineer, R&D Process Development

Posting Country
US - United States