Engineer II"

Title: Engineer II
Duration: 12 Months
Location: Fully onsite during training– then hybrid, Lake County, IL
Pay Rate starts at: $40/hr

Job Description

Client is looking for a Systems Engineer to join their Product Development, Sciences and Technology team in Operations. This individual will contribute to the development and launch of new commercial drug / device combination products. These devices enable the delivery of innovative medicines targeted at difficult-to-cure diseases with the goal of making a remarkable impact on people’s lives.

As a Systems Engineer, you will be responsible for integration of inputs and risks from multiple disciplines to ensure the development of a robust patient-centric product design and with reliable performance

 Job Responsibilities:

You will be a core member of the combination product development team responsible for the implementation of appropriate product development engineering principles within the Design Controls process with particular focus on Design Inputs, Risk Management, Traceability, and Design Validation. It is expected that the engineering activities for which you will be responsible may be done internally and externally. The external engineering activities will require you to develop and foster relationships with Engineering Services firms and third-party development partners who may be in Europe, Asia, and US, and in addition to regular teleconferences, will require periodic face-to-face visits.

You will be responsible for driving the following activities/deliverables:

• · User and Stakeholder Needs Definition
• · System/Sub-system Requirements Definition
• · System Architecture & Integration
• · Use Case Analysis
• · Traceability
• · Standards Coverage Analysis
• · Risk Management Planning and reporting
• · System Risk Assessment
• · Use Related Risk Assessments
• · Integration of Third-Party and Drug Product Development activities
• · Design Validation Planning, protocols, and reports
• Flexible Assignment Responsibilities:
• · Lab Support: Execute test protocols supporting exploratory and verification testing, analyze data, document in lab notebooks, and present results to cross-functional teams. Experience using Zwick (UTM), machine shop equipment, 3D printers is required. Familiarity with fixture development, volumetric accuracy equipment, viscometers, climate chambers, etc. is a plus.
• · Test Methods: Develop, validate, and transfer test methods.
• · Design Verification: Author verification protocols and reports. Support investigations and issue resolutions.
• · Software Tools: Electronic Lab Notebook (ELN) software and electronic DHF tools such as Polarian are preferred. Experience with Minitab and Matlab is a plus.
• · Work in an independent manner under the guidance of a supervisor or technical lead.
• · Complies with applicable policies and procedures, regulatory and safety requirements.

 

Qualifications

• You will be responsible for providing technical leadership in your areas of responsibility and ensuring the systems design and documentation meet all safety and global regulatory compliance requirements.
• · It is expected that you will work with the development team to resolve key project hurdles and to identify, communicate, and mitigate project risks.
• · Expertise in product development from initial concept to release to market is required with experience in combination product or medical device development and familiarity with FDA 21 CFR Part 820.30, 21 CFR Part 4, ISO14971, ISO 13485 and EU MDR preferred.
• · Expertise in various Systems Engineering activities including user and stakeholder need definition; requirements definition and management; risk management, product architecture, configuration management, traceability, change management and design validation.
• · The candidate must have strong analytical and communication skills and should be self-driven.
• · It is expected that you will continuously look for opportunities to simplify the ways we work to enable development efficiency without compromising quality.
• · This position will include interfacing with 3rd party vendors. Experience in vendor communication, management, deliverable acceptance testing, and multi-cultural awareness will help make you successful in this position.

Experience:

• · BS in Engineering, Science, or closely related discipline with 3+ years of experience or MS or higher with 2+ years of experience
• · Ability to multitask and work within timelines.
• · Demonstrated scientific writing skills and strong verbal communication skills.
• Position will be hired based on level of experience.
•  

 

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
 
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LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer. 


At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $40.00/hr.