Quality Sr Engineer I

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.

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.

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

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

EOE/M/F/Vet/Disability