Systems Engineer

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The Opportunity
Description
We're looking for a Systems Engineer , working in Pharmaceuticals and Medical Products industry in 375 N Field Dr, Lake Forest, Illinois, 60045, United States .
Job description:

• Responsible for end-to-end product life cycle management including creating and maintaining user requirements, product requirements, risk files, establishing and publishing traceability, and providing support to PGS on-market product support and maintenance for new products, under the coaching of a senior member on the team.
• Responsible for documentation generated in support of product development and submissions, and may also be responsible for on-market product documentation.
• Determines the DHF Structure and Owns the Requirements and Risk Management File.
• Responsible for DHF content generation in support of regulatory submissions with compliance to governing procedures and CFR 820.30 and CFR Part 4 Combination Products.
• Partner with other functions and Human Factors in the organization to ensure user errors or misuse are mitigated, stakeholders' requirements are addressed and met as appropriate; to provide consistent direction to cross functional teams and to instill a spirit of collaboration throughout the organization.
• Integrates multiple approaches to solve problems or optimize solutions in complex or cross functional manufacturing processes or product designs. Creates/modifies subsystems' designs for complex problems.
• Integrates subsystems and components in total systems designs; develops specifications from customer requirements.

Our Client
Our client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
Education and Experience:

• Bachelor degree with 4-5 yrs experience, OR
• Masters degree and 1-3 yrs experience in medical device or combination product industry, OR
• PhD Biomedical, Materials, Mechanical, Industrial Engineering with 0-1 years of experience

Requirement:

• Understanding of FDA and working knowledge of CFR 820.30 Design Controls and ISO 14971 Application of Risk Management to Medical Devices

Preferred requirements:

• Systems Engineering experience and working knowledge of medical plastics
• Experience with DOORS requirements management software
• Working knowledge of ISO 13485

What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible?