Engineer, Associate

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Full Time N Barrington, IL, US

6 days ago Requisition

Salary Range: $65,000.00 To $75,000.00 Annually

Location:

North Barrington

Employment Type:

Full Time

Founded in 1996,
Medical Murray is a privately owned medical device company specializing in the development, testing, and manufacturing of finished devices, components, and subassemblies. We partner with clients ranging from innovative startups to the world’s largest OEMs. Our expertise includes permanent implants, delivery systems, and complex catheters for vascular, gastrointestinal, urologic, and other interventional markets.

Our culture is driven by five core values:
Helpful, Happy, Personal Responsibility, Trustworthy and Clever & Skillful. These principles guide our work, our relationships, and our commitment to improving patient outcomes worldwide.

We offer a competitive compensation and benefits package, including medical (BCBS) and dental coverage, company-paid vision and life insurance, short- and long-term disability, HSA-eligible plans, a 401(k) Safe Harbor retirement plan, 18 days of PTO, Tele Doc access, identity protection, tuition reimbursement, voluntary life insurance, and paid time off for community volunteering.

The Associate R&D Quality Assurance Engineer position works within the Quality Department to support development project deliverables and contribute to R&D efforts from concept to production for disposable medical devices including catheters, catheter-based delivery systems, and other disposable devices for disciplines ranging from cardiology and neurology to urology. This position will work with high-performance cross-functional teams to develop products that meet the company objectives to provide goods and services that meet customer’s requirements for quality, quantity, and timeliness.

• Understand internal and external quality and regulatory standards and requirements
• Represent Quality on development teams to ensure compliance with quality management system and applicable regulatory requirements and standards
• Partner with R&D to determine and implement design controls based on risk management, customer needs and requirements, and manufacturability considerations
• Develop and update Design History Files on behalf of the customers
• Create and maintain Quality Plans for development projects
• Contribute to risk management activities compliant with ISO 14971
• Review and provide input to design and manufacturing documentation including material specifications, drawings, and manufacturing procedures, to ensure that the resulting products can be adequately manufactured
• Develop and optimize quality control inspection documentation, including inspection procedures and forms, and sample sizes based on critical design attributes, risk levels, and statistical rationale. Ensure suitable metrology is used
• Perform inspections on manufactured products
• Assist in creating test protocols, then perform and document testing according to those protocols. This includes design verification and validation testing, lot release testing, test method validation, measurement repeatability and reliability, process validation, etc.
• Train technicians and inspectors as needed
• Participate in report creation
• Review and approve lot history records and other quality records and project documentation to ensure compliance
• Contribute to and review nonconformance reports, temporary deviation orders, corrective and preventive action reports, and other quality records
• Ensure design input/output documentation is complete and compliant, and…