Senior Design Assurance Engineer (Medical Devices)

Zimmer Biomet; Minnetonka (MN); On-site; USD 90,000 - 110,000; Full time

Job summary

Zimmer Biomet is seeking a design assurance engineer to partner with marketing, field clinical, R&D and operations in developing and launching new products and improvements. You will manage design history files, drive verification and validation, and guide teams through risk management activities to meet regulatory standards.

The role spans hardware, software, and integrated systems with emphasis on medical imaging, fiber optics, and compliant product development under ISO 13485 and related

Qualifications

• Bachelor's degree in engineering.
• 5 yrs min product development experience in software and capital systems, and preferably also sterile disposables, in a Quality role.
• 3 yrs min software quality assurance experience, driving scoping of and protocol development for regression testing.
• Experience with medical imaging systems and/or fiber optics is desired.
• Proficient in driving risk management activities.
• Technical skills in test method development and validation.
• Understanding of RoHS, Reach, etc. European requirements, as well as EMC/EMI requirements desired.
• Experience in New Product Development activities, including requirements definition and verification and validation.

Responsibilities

• Review and approve project plans, goals, schedules, and risk management approaches.
• Provide technical direction for development teams and assist in problem resolution.
• Write protocols, test procedures and reports for design verification and validation.
• Coordinate manufacturing launch of new or revised products and transfers to production.
• Represent quality on cross-functional teams to improve current and new designs.

Skills

Strong communicator

Quality orientation

Problem analysis

Project management

Education

Bachelor's degree in engineering

Job description

Zimmer Biomet is seeking a design assurance engineer to partner with marketing, field clinical, R&D and operations in developing and launching new products and improvements. You will manage design history files, drive verification and validation, and guide teams through risk management activities to meet regulatory standards.

The role spans hardware, software, and integrated systems with emphasis on medical imaging, fiber optics, and compliant product development under ISO 13485 and related