Senior Design Assurance Engineer – Medical Devices

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

Job summary

Zimmer Biomet, a global medical technology leader, seeks a design assurance engineer to partner with marketing, field clinical, R&D and operations in developing and launching new products and improving existing ones. You will help create design history file deliverables and drive testing and verification activities.

You will provide technical direction, review project plans, and write protocols and test reports, while guiding risk management across software, hardware and integrated systems, in

Qualifications

• Bachelor's degree in engineering.
• 5+ years in product development for software and capital systems, in a Quality role.
• 3+ years software quality assurance with regression testing protocols.
• Experience with medical imaging systems and/or fiber optics desired.
• Knowledge of RoHS, Reach and EMC/EMI requirements.
• ISO 13485, ISO14971, IEC 60601-1-2 and CSA compliance knowledge.
• Experience in New Product Development including requirements verification and validation.

Responsibilities

• Partner with marketing, field clinical, R&D and operations in development and launch of new products.
• Drive design verification and validation protocols and test method development.
• Manage product development deliverables through specs, reviews and preproduction transfers.
• Provide technical direction for development teams and brief senior management.
• Coordinate manufacturing launch of new/revised products and train team members.
• Represent quality on cross-functional teams and perform risk analyses.

Skills

Strong communicator

Project management

Problem analysis

Quality orientation

Independent worker

Education

Bachelor's degree in engineering

Job description

Zimmer Biomet, a global medical technology leader, seeks a design assurance engineer to partner with marketing, field clinical, R&D and operations in developing and launching new products and improving existing ones. You will help create design history file deliverables and drive testing and verification activities.

You will provide technical direction, review project plans, and write protocols and test reports, while guiding risk management across software, hardware and integrated systems, in