Quality Sr Engineer I

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

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 talent 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 included, respected, empowered and recognised.

What You Can Expect

As a member of the engineering staff, the design assurance engineer is responsible for partnering with marketing, field clinical, R&D and operations engineering in the development and launch of new products and design improvements to existing products to assist in the development of design history file deliverables. Recommends and implements improvements to design based on post market feedback. Assists in scoping required software and system testing based on proposed changes, drives design verification and validation protocol and test method development. Manage product development deliverables with the team through specification development and review, verification and validation, design reviews, documentation packages, preproduction builds and transfers to production.

How You'll Create Impact

Assists in the review and approval of project plans, including goals and objectives, work breakdown structure, detailed scope descriptions, detailed schedules, risk management approach, milestone descriptions for software and integrated system projects. Provides technical direction for development teams, serves as a point of contact or business liaison, prepares briefings for senior management and assists in problem resolution specific to the program/project. Writes protocols, test procedures and reports. Drives risk management file activities and updates. Participates in project teams and all activities related to the development of new products.

Furthermore, this person

• Must be strong both in mechanical system design (electronics, pneumatics, lasers, fiber optics) and software design (software as a medical device). This role would be developing or reviewing all design history deliverables for hardware, software, and the integrated system.
• Must be capable of guiding marketing spec, product spec, design specs, etc. with marketing and R&D for the NeuroBlate system and sub-assemblies and components.
• Must be capable of writing software and hardware design verification and validation protocols, reviewing reports
• Will assist as required in all aspects of the design and development phases in accordance with ISO 13485, ISO14971 Risk Management, IEC 60601-1-2, and CSA regulations.
• Performs research, design and development of test methods used in Design Verification and Validation
• Coordinates the manufacturing launch of new/revised products including establishing goals, training team members and evaluating results.
• Represents quality on cross-functional teams to improve current product and new product design
• Performs Risk Management Activities such as risk analysis and human-factors studies.

What Makes You Stand Out

• Strong communicator who works independently to make decisions and drive projects but communicates status to manager and team members appropriately
• Quality orientation and attention to detail.
• Problem analysis and problem resolution
• Strong project manager with proven experience in managing and prioritizing many different projects in a fast paced environment

Your Background

• 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 required based on changes in code design
• 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.

Expected base salary is $90,000 - $110,000 plus annual bonus

Physical Requirements

Travel Expectations

EOE/M/F/Vet/Disability