Job opening

Design Engineer

Net2Source (N2S)

Richmond, IL

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


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