Engineer: Process Improvement Engineer
BS-level Process Engineering roles on Crosslinked list a median of $112k (565 that show pay).
Lead injection molding process development and validation for medical diagnostic devices
Worth knowing
Why it is interesting. Hands-on role with FDA validation and injection molding in a growing medtech company.
Might not be for you. Requires 5+ years of injection molding experience and ISO 13485 background.
Adjacent materials roleInjection Molding Experience Required; 5 years of experience in resins, and scientific mold process development
- Seniority
- Mid-level
- Work
- On-site
- Type
- Full-time
- Degree
- BS
- Experience
- 5+ yrs
- Industry
- Medical devices
- Role
- Process Engineering
Role details
Nanobiosym is on the cusp of rewriting the rules of personalized medicine, novel technologies, and healthcare delivery. Founded by a renowned MIT and Harvard trained Physician and Physicist, Nanobiosym's innovative pipeline of products leverage novel advances in physics, biomedicine, and nanotechnology. Awarded the first ever X-PRIZE for healthcare, and a recipient of multiple other prestigious peer-reviewed funding awards, Nanobiosym is currently adding to its talented team as it expands into a global commercial enterprise.
DUTIES
- Injection Molding Experience Required
- Coordinate a production and Engineering Team in a variety of manufacturing processes.
- Collaborate with team members and management to develop and improve injection molded and assembled products and processing thru numerous manufacturing steps.
- Develop and assist in the process and product monitoring, including the creation of a validation protocol (IQ, OQ, PQ) that comply with FDA regulations.
- Utilizes DOE/DRM/COS/Lean principles and statistical process control to develop creative, thorough and practical technical solutions.
- Provide troubleshooting focus and direction for the team with details of root cause analysis.
- This is a hands-on position in a growing organization and an opportunity which will grow rapidly
QUALIFICATIONS
- MS. or B.S. in Engineering (Plastics or Mechanical preferred)
- Six Sigma Black Belt, a plus
- 5 years of experience in molding highly critical dimensional parts in manufacturing environment
- 5 years of experience in resins, and scientific mold process development
- Demonstrated experience with viscosity analysis, ultrasonic and electric contact welding
- Experience in statistical analysis and statistical process control
- Recent experience with a ISO 13485 environment
- Good Communication and Organizational Skills
- Master molder certified preferred
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