Quality Sr Engineer I

Biomet Microfixation, LLC•Minnetonka, MN

7d•$90,000 - $110,000

About The Position

As a member of the engineering staff, the design assurance engineer partners with marketing, field clinical, R&D, and operations engineering to develop and launch new products and improve existing products. The role supports development of design history file deliverables and recommends and implements design improvements based on post-market feedback. It scopes software and system testing for proposed changes and drives development of design verification and validation protocols and test methods. The engineer manages product development deliverables with the team, including specification development and review, verification and validation, design reviews, documentation packages, preproduction builds, and transfers to production. The role provides technical direction to development teams, supports project planning and problem resolution, and develops protocols, test procedures, and reports. It also works across hardware, software, and integrated-system design history documentation for the NeuroBlate system, supporting development in accordance with applicable quality and regulatory standards.

Requirements

Bachelor's degree in engineering.
At least 5 years of product development experience in software and capital systems in a Quality role.
At least 3 years of software quality assurance experience, including scoping and developing protocols for regression testing required by code design changes.
Proficiency in driving risk management activities.
Technical skills in test method development and validation.
Experience in new product development activities, including requirements definition and verification and validation.
Strong communication skills and ability to work independently, make decisions, drive projects, and appropriately communicate status to the manager and team.
Quality orientation and attention to detail.
Problem analysis and problem resolution skills.
Strong project management skills, including managing and prioritizing multiple projects in a fast-paced environment.
Strong capabilities in mechanical system design, including electronics, pneumatics, lasers, and fiber optics, and in software design, including software as a medical device.

Nice To Haves

Experience with sterile disposables.
Experience with medical imaging systems and/or fiber optics.
Understanding of RoHS, REACH, other European requirements, and EMC/EMI requirements.

Responsibilities

Partner with marketing, field clinical, R&D, and operations engineering on new product development and improvements to existing products.
Support development of design history file deliverables and recommend and implement design improvements based on post-market feedback.
Scope required software and system testing based on proposed changes.
Drive development of design verification and validation protocols and test methods.
Manage product development deliverables, including specifications, verification and validation, design reviews, documentation packages, preproduction builds, and production transfers.
Assist in reviewing and approving project plans for software and integrated system projects.
Provide technical direction to development teams, serve as a point of contact or business liaison, prepare senior management briefings, and assist with program or project problem resolution.
Write protocols, test procedures, and reports.
Drive risk management file activities and updates.
Participate in project teams and activities related to developing new products.
Develop or review design history deliverables for hardware, software, and integrated systems.
Guide development of marketing, product, and design specifications with marketing and R&D for the NeuroBlate system, subassemblies, and components.
Write and review software and hardware design verification and validation protocols and reports.
Support design and development phases in accordance with ISO 13485, ISO 14971, IEC 60601-1-2, and CSA regulations.
Research, design, and develop test methods for design verification and validation.
Coordinate manufacturing launches of new or revised products, including establishing goals, training team members, and evaluating results.
Represent quality on cross-functional teams to improve current and new product designs.
Perform risk management activities, including risk analysis and human-factors studies.