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
