Job opening
Design Engineer
Filed under Medical Equipment Manufacturing
Full job description
Title: Engineer - Design (Senior Level)
Location: 100% onsite at 5205 Route 12 | Richmond, IL 60071, USA
Shift: Standard day shift, Mon–Fri, 8 hr/day
Duration: 2 months (Possible Extension)
Job Description:
Candidate will be working with design engineering and project management leading a consumable NPD project and supporting Design History File (DHF) remediation.
Objective:
Qualified Engineer capable of leading a cross-functional project team and executing on design technical documentation.
Scope of Services
a. Project Management Leadership
i. Lead an NPD team, managing weekly meetings coordinating activities between global sites
ii. Coordinate on-site teams regarding V&V testing, process validation and equipment installations.
b. Design & Sustainment
i. Scale-up and Test Method Development
1. Blending, formulations Testing
2. Bottled Liquid Primary and Secondary Packaging Design
ii. Author and review DHF artifacts including
1. Product requirements and specifications
2. Risk management files
3. Verification testing protocols and reports
4. Understanding of statistical analysis and Design of Experiments (DOE)
c. General
i. Proficient in MS Office
ii. Basic understanding of quality systems, e.g. ISO9001, ISO13485
Minimum Qualifications
a. Required
i. Bachelor’s degree in engineering or related degree.
ii. 2+ years experience in a regulated industry with design controls requirements