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Job Description:
Location:
Remote - Eastern and Central Time zone strongly preferred
Description:
In this role is to perform all the write up for formal verification and validation testing, as well as product development studies. This includes plans, protocols, reports, and engineering summaries. Experience with the design control process and its deliverables is required. Candidates for this assignment should be familiar with GMP.
Responsibility Breakdown:
- Develop and update process documentation including assembly procedures, test procedures, routers, travelers, BOMs, process flows, and process FMEAs.
- Assist engineering team to qualify develop Design Verification and Validation documentation (protocol and report), Gage R&R Studies, Process Capability Studies and Designs of Experiments and other technical documentation.
- Maintain accurate documentation of concepts, designs, and processes while maintaining current knowledge of medical and technical developments related to company products.
Top Skills:
writing skills, technical writing, engineering, knowledge of GMP
Additional Skills & Qualifications:
Development of process documentation - assembly procedures, test procedures, routings, BOMs, process FMEAsEngineering experience - 2 to 5 years to demonstrate understanding of Design Verification and validation docs, Gage R&R studies, Process Capability Studies, DoEsPLEASE NOTE: Compensation is tied to the Colorado market for jobs performed in Colorado. Other locations may be subject to variances based on locations-related factors. We reserve the right to pay above or below the posted wage based on factors unrelated to sex, race, or any other protected classification.
Eligibility requirements apply to some benefits and may
depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. This temporary role may be eligible for the following:
- Medical, dental & vision
- 401(k)/Roth
- Insurance (Basic/Supplemental Life & AD&D)
- Short and long-term disability
- Health & Dependent Care Spending Accounts (HSA & DCFSA)
- Transportation benefits
- Employee Assistance Program
- Time Off/Leave (PTO, Vacation or Sick Leave)
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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