What are the responsibilities and job description for the Sr. Manufacturing Engineer position at Redbock - an NES Fircroft company?
Sr. Manufacturing Engineer (Through mid-August 2025 // Boulder, CO):
Join a leading medical device manufacturer as a Sr. Manufacturing Engineer, working within the Robotic Instruments product line. This role is in support of the Lead Manufacturing Engineer during development and validation.
W2 ONLY (Unable to work C2C or Sponsor Visa)
Top 3 Skills Required:
- Process Validation
- PLM Experience (Agile preferred)
- Gage R&R
Education: Bachelor’s Degree is required, preferably in Engineering
Target Years’ Experience: 4 years of manufacturing minimum, ideally with some exposure to Medical Device production
Description:
This role will support a lead manufacturing engineer during development and validation of a new production lines for a new medical device. Responsibilities include, but are not limited to:
- Support development and validation for new production processes.
- Manage product BOM configurations in PLM system.
- Develop and characterize the manufacturing process window and secure process capability across all variation in production materials and processes.
- Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
- Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions. These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.
- Provide engineering support to manufacturing operations and address quality issues arising on the production floor.
Minimum Requirements
- Bachelor’s Degree in a technical discipline
- Minimum 4 years of manufacturing experience
- Experience with Process Validation
- Experience with Gage R&R Analysis
- Experience updating product/process information with a PLM system
Nice to Have:
- Experience with Agile PLM
- Master’s Degree in a technical discipline
- Medical Device and/or Manufacturing Experience
- Experience developing vision inspection/verification systems
- Experience with vision inspection system programming
- Experience in an electronics manufacturing environment
- Experience authoring PFMEAs
- Experience with materials joining process, such as laser welding, ultrasonic welding, or resistance welding.
- Basic knowledge of Leak Tester machines
- Laser marking experience
- Ability to use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in medical device manufacturing
Past participation and investigation of atypical events to support product disposition
