Software Project Lead

FULLTIME: 12-Month Assignment
LOCATION: Valencia CA (Hybrid 3/2)
SCHEDULE: Business Needs
PAY RANGE: $70/HR
(Exact compensation may vary based on skills experience and location. Base pay information is based on market location.)

JOB DESCRIPTION:
This role serves as the primary owner for software activities aligning technical execution with business objectives regulatory expectations and product roadmaps.
As a key member of the Software group and is critical to accelerating innovation through acquisition while maintaining patient safety regulatory compliance and software quality. The Software Project Lead ensures that acquired software technologies are seamlessly and responsibly integrated into the medical device portfolioturning strategic investments into safe effective products for patients.

Responsibilities:
Leading the planning and execution of complex software development and integration software.
Partnering closely with R&D Quality Regulatory IT Cybersecurity Clinical Operations and other cross-functional teams to develop software solution into the companys medical device portfolio while ensuring compliance with global regulatory standards and internal quality systems.
Develop and maintain plans covering software development verification/validation cybersecurity and regulatory deliverables.
Manage program schedules budgets resources risks and interdependencies across multiple cross functional teams.
Provide clear data driven program status risks and decision points to R&D leadership.
Drive alignment between legacy and acquired development processes tools architectures and documentation.
Work closely with software engineering teams to ensure development and integration activities comply with applicable standards.
Ensure proper integration of software lifecycle artifacts including requirements architecture risk management verification validation and cybersecurity documentation.
Support design reviews phase gate reviews and regulatory submissions related to integrated software products.
Facilitate alignment on system architectures interfaces data flows and platform strategies across organizations.
Drive issue resolution and decision making across organizational boundaries.
Track software project progress and provide transparent communication and interfaces with all areas affected by the project including cross-functional stakeholders business sponsors and senior management.
Conduct retrospectives and lessons learned and implement process improvement initiatives to drive future success.
Additional duties as assigned.

Key Competencies and Capabilities
Ability to plan and execute software projects in the medical device industry with preferred experience in medical device software including new product development and sustaining software.
Working knowledge of the software development lifecycle (SDLC) in a regulated environment with exposure to agile or hybrid delivery models.
Proficiency with project management and software delivery tools (e.g. MS Project JIRA) including development of WBS schedules and dependency tracking.
Working understanding of software day to day challenges and system level integration sufficient to support cross functional execution.
Strong verbal and written communication skills with the ability to collaborate across Software Systems Quality and Regulatory teams and drive on time delivery.
Demonstrated organizational and problem solving skills with the ability to manage assigned scope and operate effectively within a regulated quality driven environment.

Required Qualifications:
Bachelors degree in engineering Computer Science or related technical discipline.
Software Development experience 5 years minimum C# WPF Minimum 5 yrs.. hands on development experience
Web technology Experience 2 yrs prefered
10-15 years of experience in software project management within software driven medical devices or other regulated industries.
Demonstrated experience leading cross functional software development programs.
Strong understanding of regulated software development lifecycles and quality systems.
Proven ability to manage complex ambiguous programs with multiple stakeholders.

Preferred Qualifications:
Familiarity with FDA EU MDR and global regulatory expectations for software enabled medical devices.
Experience with cybersecurity cloud connected devices.
PMP PgMP Agile or SAFe certification.
Masters degree in Engineering Management or related field.

WORKING CONDITIONS:

• May on occasion be exposed to loud sounds and distracting noise levels such as from office equipment.
• The ability to lift up to 30lbs
• Use of computers and technology

Here at Canon Recruiting People are our priority and we are committed to Include Diversity in every segment of who we are. It is only through our Diversity we are made a stronger organization and increase our ability to provide top tier candidates that our clients have come to know Canon for. We have an inclusive environment all employees are celebrated for their unique differences. The different perspectives and experiences of our workforce give us the competitive advantage that is essential for success in an ever-changing market. By promoting inclusion with the same enthusiasm we devote to quality and competency and using the experience from a diverse assortment of backgrounds and experiences Canon is able to improve the services and value we deliver to clients employees and customers. At Canon Diversification and Inclusiveness are much more than a corporate ambition; they are a critical component in our daily corporate life.

Canon Recruiting is committed to a diverse and inclusive workplace. Canon Recruiting is an equal opportunity employer and does not discriminate on the basis of race national origin gender gender identity sexual orientation protected veteran status disability age or other legally protected status.

The pay range for this position is listed above. Base pay information is based on market location.
We will consider for employment qualified applicants with arrest and conviction records. Our range of benefits may include health care and 401(k) savings plans.
For individuals with disabilities who would like to request an accommodation please email our HR team.

Required Experience:

Senior IC