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POST DATE 5/6/2020
END DATE 7/5/2020
Lake Forest, IL
We are currently searching for a skilled professional to join a well-known client's team as a Systems Engineer in Lake Forest, Illinois. The Systems Engineer role will manage the end-to-end life cycle of new products while providing support to on-market products and documentation. This client has one of the strongest reputations in the clinical business to add to your career and resume.
* Determine the Design History File (DHF) structure
* Maintain the Requirements and Risk Management file
* Generate the DHF content to support regulatory submissions with compliance to governing procedures and CFR 820.30 and CFR Part 4 Combination Products
* Ensure user errors or misuses are mitigated and organizational stakeholders' requirements are addressed and met
* Provide consistent direction to cross functional teams and instill a spirit of collaboration throughout the organization
* Integrate multiple approaches to optimize solutions in complex or cross-functional manufacturing processes/product designs
* Create or modify subsystem designs for complex problems
* Integrate subsystems and components into total system designs
* Develop specifications from customer requirements
* Minimum of 3 years of experience in medical device or combination product industry required
* Strong understanding of the four key elements of Risk Management required
* Understanding of FDA and working knowledge of CFR 820.30 Design Controls
* Knowledge of ISO 14971 Application of Risk Management to Medical Devices
* Experience in Systems Engineering
* Knowledge of medical plastics preferred
* Experience with DOORS requirement management software
* Detailed knowledge of ISO 13485 preferred
* Minimum of Bachelor's Degree in Biomedical, Materials, Mechanical, or Industrial Engineering required
* Master's Degree or PhD preferred
To be a best-fit your strengths must include:
* Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
* Organized. You're an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
* Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
* Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
* Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
* Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.