Job Category: Manufacturing Engineering
Job Number: 11610788
Women Back to Work (WBW) candidates will also be considered for this position.
Akraya is looking for a NPI Manufacturing Engineer for one of our clients. If the job description below is a fit, please apply directly or call Moiz at 408-816-2442. If this position is not quite what you’ re looking for, visit akraya.Com and submit a copy of your resume. Our recruiters will get to work finding you a job that is a better match at one of our many clients.
Primary Skills: NPI, Manufacturing, BOMS, Designing, Validation
Duration: 5+ Months
Tax Term: W2 Only
Roles and Responsibilities:
- Work with team to create, maintain and improve pilot “ mid-volume” manufacturing assembly line, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions.
- Design, document, procure, qualify, implement, and improve fixtures, tools and equipment.
- Analyze instrument manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing.
- Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ).
- Provide production support through successful and sustained project launch.
- Support identification of and implementation of continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction.
- Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.
- Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation.
- Provides technical support analyzing and/or performing failure analysis for discrepant production components, assemblies and field returns.
- BS / MS degree in Engineering discipline or equivalent work experience.
- 5-7 years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content.
- Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.
- Prior responsibility for process, equipment or product validation/verification.
- Prior experience with process development, design of automated equipment, complex mechanism manufacturing is a plus
- New product introduction/development desirable. Robotics knowledge a plus.
- CAD experience (preferred Solidworks).
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus
Please apply directly with your update resume or call Moiz at 408-816-2442
Akraya, Inc. Is an award-winning staffing firm that works with many of the leading, technology-based companies around the world. We have been ranked as one of the “ Best Staffing Firms to Temp for” by Staffing Industry Analysts on multiple occasions and are a preferred staffing vendor within numerous staffing programs. Please visit akraya.Com to search through all of our current openings or to submit your resume to our recruiting team.