What are the responsibilities and job description for the Sr Manufacturing Engineer – Medical Device position at Grove Technical Resources, INC?
Job Title: Sr Manufacturing Engineer – Medical Device
Job Location: Boulder, Colorado (Fully Onsite)
Type: W2 Contract
Duration: 12 Months
Job Description:
1. Process Validation
2. PLM Experience
3. Gauge R&R
Years’ Experience Required: 4 years minimum
This position is for a Manufacturing Engineer. This role will support a lead manufacturing engineer during the development and validation of 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 the PLM system.
Develop and characterize the manufacturing process window and secure process capability across all production materials and process variations.
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 supporting manufacturing protocols, reports, changes, and 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 experience required.
Nice to Have:
Master’s Degree in a technical discipline
Medical Device and/or Manufacturing Experience
Experience with materials joining processes, such as laser welding, ultrasonic welding, or resistance welding.
Laser marking experience.
Experience developing vision inspection/verification systems.
Experience in an electronics manufacturing environment.
