Sr Digital Manufacturing Engineer

North Bay, (none selected) | Direct Hire

Post Date: 06/27/2017 Job ID: JOS000006752 Industry: Software/Hardware

Sr. Digital Process Engineer

 

Individual will be a key member of a medical device product development team, leading activities associated with product development/manufacturing transfer.  The individual will be responsible for leading the Digital Manufacturing team in areas such as: manufacturability, cost reduction, process control/characterization, documentation, validation, and production support.  Additionally, the individual will be serve as technical interface with key suppliers.  The Sr. Digital Manufacturing Engineer is intended to be a versatile position capable of supporting/Leading project/program needs based on the company’s goals and objectives. This person will be expected to exercise judgement within generally defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned as necessary):

 

  1. Will be responsible for the design of custom eartips and associated products through the use of 3D scanning, design and 3D printing
  2. Establishment of process flow and production line layouts
  3. Process development/statistical analysis
  1. Lead and contribute to engineering efforts from planning and organization to execution and delivery to solve complex engineering problems in infrastructure, tools and testing.
  1. Perform process validations (IQ/OQ/PQ)
  2. Write protocols and test reports
  3. Develop the organization’s core competency by selecting equipment, software and conducting training courses
  4. Ability to work in a fast paced dynamic environment
  5. Project management/supervision experience
  6. Act as the Operations representative on R&D cross-functional project teams
  7. Transfer new products from R&D to Manufacturing through the design control process

 

 

QUALIFICATIONS:

 

  • Hands-on individual with demonstrated experience in the design and development of custom eartips through the use of additive manufacturing
  • Ability to solve problems using structured methods.
  • Attention to detail in process characterization and documentation.
  • Ability to lead complex projects and work in a team environment
  • Have a firm understanding and demonstrated experience performing medical device process validations.

 

  • Firm understanding of manufacturing techniques with ability to quantify line capacities and to develop high volume manufacturing scale-ups.

 

  • Statistical Process Control, Green Belt experience preferred

 

  • Experience utilizing 3D printing, Geomagic Studio, Rhinos, 3Shape and Solidworks to produce custom hearing components preferred

 

  • Fluent using Word and Excel.

 

  • Good written and verbal communication skills

 

 

EDUCATION and/or EXPERIENCE:

 

  • BS Degree in Engineering or equivalent
  • Manufacturing experience with custom products preferably RIC or CIC eartips
  • Ability to work in a fast-paced environment.
  • Ability to multi-task and interact well with others.
  • Experience in experimental techniques, statistical analysis & engineering investigation techniques (six sigma green belt preferred)
  • 5 years experience in leading projects
  • 5-10 years experience in medical device manufacturing experience

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