Systems Engineer II job in Milwaukee, WI
Vacancy has expired
Milwaukee, WI CorTech LLC
| Job Ref: | 344511 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 50.72/Per Hour |
| Remote: | No |
Location |
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| City: | Milwaukee, WI |
| Post Code: | 53224 |
| Map: |
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Description |
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CorTech is seeking to hire a Systems Engineer for our client in Milwaukee, WI! Benefits Available! Weekly Pay! $50.72/Hour Description: Position Summary: Responsible for coordination and management of system design for one or more groups of related products to achieve defined program goals. This includes maintenance and engineering support of existing products. Interfaces with other departments including Marketing, Sales, Service, Operations, Quality Assurance and Regulatory Affairs to define product requirements, communicate important information, and address issues relative to each product. Position Responsibilities: - Participate as a member of project teams for the assigned program. - As a member of the technical team, ensure technical product requirements are communicated and understood by the technical staff. - Have knowledge of Design Control per 21 CFR Part 820 and ISO 13485. Responsible for ensuring technical product requirements are clearly and thoroughly documented. This includes the following: o Creation of system level specifications. o Technical resource for Risk Management per IEC 14971. o Coordination and review of design level requirements to ensure they meet the system requirements and market needs. o Coordination of DFMEA workshops o Responsible for DHF traceability by ensuring all requirements have been verified and validated. This includes creation of Verification and Validation Plans to scope the extent of testing required to maintain adequate traceability is maintained during a development project. This also includes completion of all documentation required to ensure compliance to standards. o Ensures requirements shared by similar products and their implementations are harmonized across those products, where possible. o Ensure requirements shared by similar products and their implementations are harmonized across those products, where possible. - Work with technical writing to ensure user documentation is sufficient. - Understand product configurations to support applicable codes and standards testing - Member of cross functional support team. Specific duties are as follows: o Assist with EU MDR remediation activities. o Participate in CAPA activities as needed. o Resource for Post Market risk assessments. o Resource for Field Action Determinations. o Performs other duties as requested. Education, Experience, Qualification, and Skills: Bachelor's Degree in Engineering or related field and/or equivalent experience and 2+ years of experience. Must have medical device experience, preferably with cardiology devices. Must have strong organizational skills. Must be fluent in English (both oral and written) with excellent oral and written communication skills. Works independently, is self-motivated and able to complete tasks with minimal supervision. Must have the ability to initiate and develop creative solutions. Acts with a sense of urgency, escalates issues as needed, illustrates ambition and drives for completion of tasks/projects. Strong proficiency in Office applications skills. Must be a team player and be self-motivated. Possess good listening skills, and easily learn new skills and concepts. Ability to manage time and prioritize work. Must be flexible and adaptable. Must demonstrate the ability to increase knowledge. Physical demands and work environment: Physical Demands: While performing the duties of this job the employee will be sitting for extended periods, will need to use a computer/mouse/keyboard/monitor and will communicate and listen both in-person and over the phone. Work environment: The work setting is an office environment which has minimal noise level. | |
ref: (344511)
1027 days ago
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