At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talented team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels inspired, invested, cared for, valued, and have a strong sense of belonging.
What You Can Expect
The Associate Design Quality Engineer is a quality engineering position that has emphasis on developing and maintaining Paragon 28’s quality system and related quality activities specifically relating to the day-to-day production, manufacture, and release of Paragon 28 patient specific implants. The Associate Design Quality Engineer participates on project teams as a contributing member by providing quality engineering support under the direction of Sr. Design Quality Engineers & management in the development, production, and continuous improvement of products and processes. This is an onsite position at our Paragon 28 location in Englewood, Colorado with occasional opportunities for remote work.
How You'll Create Impact• Assist in Design Control and Transfer for release of patient specific projects.
• Assist in maintenance of the Design History File for patient specific products.
• Perform Mechanical Inspections and use typical equipment used in inspection.
• Provide support for the manufacturing areas (internal and external). Work with production personnel and supervision to determine and monitor quality metrics, samples plans and address non-conforming product issues. Lead corrective and preventive action investigations to resolve the root cause of problems.
• Aid in development of acceptance criteria and measurement techniques for new product release.
• Participate in risk management activities in compliance with ISO 14971 as expressed in the company’s Quality Management System.
• Assist in the development and execution of process validations with suppliers.
• Participate in supplier qualification process. Interface with suppliers to ensure product compliance to specification and perform supplier audits as needed.
• Aid in creation and review of procedures, plans, protocols and reports to ensure regulatory compliance.
• Assisting project teams on compliance with design control requirements per FDA QSR, European MDR, ISO 13485 and other applicable ISO/EN standards.
• Accurately represents quality processes to 3rd party auditors (FDA, ISO 13485, MDSAP, etc.).
• Other duties as assigned.
Qualifications
• Bachelor’s in Engineering or technical discipline and 0-2 years of related experience
• Familiarity with 21 CFR 820 and ISO 13485:2016 and other Government / ISO Standards
• Preferred Medical Device Design Controls
• Technical writing skills that include Quality Management Systems (QMS) and procedures
• Preferred Verification and Validation experience
• Knowledge in Machining methodologies preferrable (Titanium and Cobalt Chrome experience best), knowledge of 3D printing preferrable (Titanium, Cobalt chrome, Nylon), knowledge of hardness, heat treatment, passivation, surface treatments, coatings, cleaning techniques etc. for communication with Suppliers and Engineers
• Preferred knowledge of ASTM F3001, ASTM F2924, ASTM F3213, and ASTM F75
• Basic computer skills (MS Office)
Work Environment
This job operates in an office and warehouse environment. This role routinely uses standard office equipment such as computers, phones and copy machines.
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is regularly required to communicate with individuals internal and external to the organization. The employee is required to have close visual acuity to perform activities such as inspecting small parts, viewing computer terminal and reviewing reports. The employee frequently is required to move about the facility. The employee may be required to lift up-to 15 lbs. by themselves.
Position Type/Expected Hours of Work
This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager.
Less than 10% overnight travel. Supplier travel might be needed for on-site trouble shooting, validation activities, and/or audits.
Compensation DataAnnual Salary Range: $60,000 - $73,000 USD
EOE