Sr Engineer Process Design

BSME with 5+ years of Medical Device experience. R&D experience is essential. DFM and automation
Full Time, Permanent
Depends On Experience
Telecommuting not available Travel not required

Job Description

In this role, the Engineer will use sound and proven engineering principles, best practices and concepts in order to assist in developing processes and process requirements from internal and external stakeholders.  Working as a member of a technology team, this engineer will collaborate and communicate with other engineers, management, and operators.

As a member of the R&D Advanced Technology team this engineer will lead efforts to understand current and future needs of our manufacturing and automation processes, explore and evaluate new technologies and concepts for meeting those needs, and rapidly demonstrate feasibility of such technologies through rigorous modeling, analysis, prototyping, experimentation, and other risk identification and mitigation activities.

 

Essential Duties and Responsibilities:

  • Design, document and optimize new manufacturing process/assembly steps and operating procedures for new stations, equipment, and processes within a regulated quality system. 
  • Demonstrate hands-on process understanding and provide guidance and training with pilot plant operators on engineering level builds. 
  • Develop and maintain project timelines and provide updates and feedback to project leadership.
  • Design and develop fixtures and equipment components required to meet process goals from concept to implementation. 
  • Create and release equipment specifications and drawings, establish calibration and preventative maintenance requirements. 
  • Provide technical oversight and coordinate Research and Development builds within a pilot production facility for multiple projects and project teams. 
  • Implement, characterize, and optimize processes, mechanical tests, and fixtures/jigs for assembly, inspection and test through implementation of measurement systems, part inspections, MSA, and capability analysis.
  • Identify process risks and track mitigations through standard methods.
  • Assist in scaling up equipment and processes from prototype to pilot to full scale manufacturing.  Provide design and assembly requirements working within scope as determined by business and schedule needs.
  • Exercise judgment within defined procedures and policies to determine appropriate action.
  • This position assumes and performs other duties as assigned.

 

Required Qualifications:

  • Typically requires a B.S. in Mechanical Engineering, Bioengineering or equivalent with 5+ years related experience, preferred or an M.S. in Mechanical Engineering, Bioengineering or equivalent with 2+ years related experience.
  • Ability to run self-directed projects, maintain timelines, transfer technology and execute projects in an R&D environment.
  • Ability to deal with ambiguity/uncertainty and a willingness to try new/challenging things.
  • Proven ability to work hands-on in a fast-paced environment.
  • Previous direct involvement in medical device industry.
  • Proficient in the use of SolidWorks or equivalent CAD software.
  • Familiar with data analysis methods and analysis software, experience in JMP or Minitab preferred.
  • Detailed oriented with strong time management skills.
  • Excellent communication (written and verbal) and personal interaction skills.
  • Familiar with sterile barriers and various sterilization methods and design/process constraints.
  • Knowledge of high reliability, high volume manufacturing processes and designs. 

 

Preferred Qualifications:

  • Medical Device experience is a strong preference
  • Experience is manufacturing or sustaining environment
  • Experience in DFA or DFSS
  • DMAIC experience

 

"We Engineer your success" Britech Group, Inc is a Technology Staffing Company who are experts in integrating exceptional people with top companies. Additional Job Openings- http://britechgroup.com

Dice Id : 10118384
Position Id : Req-1310
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