Sqa Project Manager Jobs in California (NOW HIRING)

The Lead Systems Engineer, R&D, manages large, complex, technically challenging products. They lead cross functional project efforts requiring in-depth knowledge and decision-making analysis to develop, implement or improve products. This individual has wide-ranging experience and uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Demonstrates sound judgment in selecting methods, techniques, and evaluation criteria in proposing solutions and obtaining results. They build networks with key contacts outside their own area of expertise. The role requires systems-level expertise across medical imaging workflows, interoperability, DICOM, PACS, diagnostic displays, and enterprise infrastructure.

Essential Duties and Responsibilities:

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• Maintain and expand on an expert level of understanding of our products and their use in clinical practice, using this knowledge to maintain these products as well as specify, design, develop, test and implement screening medical devices.Promotes and leads the development of knowledge throughout the organization.
• Drive a shared technical vision and contribute to the product, research, and sustaining, hardware, and technical roadmap in close partnership with Product Management and cross-functional stakeholders.Leads high level architectural discussions to conceptualize, design and develop products that can provide interoperable clinical workflow and visualization solutions for radiology.
• Ability to make effective tradeoffs between conflicting priorities, so people have confidence that all options have been considered.
• Influences the shaping of future products by contributing to the framework (architecture) used across multiple products or systems.Will vision the product from start to finish, incorporating perspectives from multiple domains.
• Provides guidance, subject expertise, customer insights, and project related tasks.
• Defines needs, feature definitions, personas, use cases, system interfaces, acceptance criteria, and system-level verification needs for projects.
• Works closely with the Product Manager in marketing and the technical teams to deliver product value and contribute to defining the platform / product roadmap.
• Provides strategic leadership and technical guidance to teams across system design, integration, deployment, upgrades, sustaining engineering, and continuous product improvement.
• Continuously studies the market, investigates and evaluate existing technology, conducts literature research, engages with the customer, and seeks feedback to gain understanding of market forces, the customer experience, and opportunities for product solutions and innovation.
• Promotes and leads the development of product knowledge and ideation throughout the organization.
• Builds and maintains relationships required to obtain deep knowledge of the customer, product users, business strategy and market dynamics. Leverages internal and external networks.
• Represents the voice of the end user within the design development cycle.
• Responsible for the definition and documentation of customer requirements including intake of initial assessment, determining priority, detailing and execution.
• Leads the development and documentation of product features, ensuring they are appropriately elaborated during the design process and include user voice.Drives the plan and eliminates obstacles to timely progression. Makes decisions as needed for project progression.
• Partners with the product marketing, service, quality, regulatory and SQA in defining detailed product / platform roadmap.
• Provides technical leadership and is a strong contributor in the NCE, CAPA and Audit process. Leads or supports root cause analysis of complex hardware, display, network, infrastructure, integration, and software issues. Responsible for execution of projects for design changes originating from Post Market Surveillance CAPA.
• Builds a workplace culture of continuous improvement. Leads the development of organizational improvements, shared best practices, and the growth and dissemination of institutional knowledge.
• Maintains strong network and relationships with Marketing, Sales, PMO, Design Assurance, Clinical Affairs and other functional partners. Leads collaborative efforts and the building of interorganizational networks.
• Establish collaborative relationships with all stakeholders and create links with experts within the Hologic network and outside. Regular travel to customer sites to grow knowledge base and bring customer driven insights back to team. Leads collaborative efforts and the building of interorganizational networks.
• Grows professional and technical knowledge with an emphasis on creating innovative solutions to solving problems and innovative product development.
• Builds a culture of agility anddrives continuous investigation and development of potential product improvements and insists on the highest levels of product quality.
• May contribute to the intellectual position of the company through invention and patent applications.

Qualifications:

Education

• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Master’s Degree

Experience

• Preferred Minimum Non-Technical Degree: 8+ Years
• Preferred Minimum Technical/Advanced Degree: 6+ Years with Master’s Degree, 3+ Years with PhD

Skills

• Expert level of understanding of our products, history of development, evolution, and their use in clinical practice
• Working knowledge of FDA regulations, including 21 CFR 820.30 – Design Controls, ISO 14971, IEC 60601, IEC 62304, GMP and other standards as they relate to the design and manufacturing of medical devices.
• Clinical and technical knowledge and skills within the field of medical imaging technologies, including medical imaging workflows, diagnostic workstations, and breast imaging applications.
• In-depth technical expertise in systems engineering principles and methodologies; knowledge and experience across software, hardware, infrastructure, networking, cybersecurity, interoperability and medical device engineering disciplines.
• Ability to lead high level architectural and technical discussions and drive system-level decisions through ambiguity.
• Demonstrated ability to think strategically, lead complex projects, allocate resources, and motivate cross functional teams.
• Critical thinking, problem solving and analytical skills.
• Strong understanding of DICOM, PACS, HL7, RIS, EHR/EMR, VNA, imaging modalities, and medical imaging workflows.
• Strong understanding of imaging workstation and enterprise hardware components, including CPUs, memory, storage, GPUs, peripherals, Windows Server and/or Linux environments. Knowledge of diagnostic display technologies, image rendering, display calibration, resolution requirements, virtualization, SAN storage, SQL databases, Active Directory, and cloud platforms is preferred.
• Exceptional verbal, written and presentation communication skills; thoughtful listener, exceptional storyteller; ability to adapt communication skills for technical and non-technical audiences.
• Strong influence management skills.Ability to persuade and effectively communicate Hologic’s position to various stakeholders to achieve operational alignment. Ability to work cooperatively at all levels in a matrix organization to build and maintain the positive relationships required to accomplish project goals.
• Strong ability to create and deliver presentations.
• Ability to understand all aspects of a product and its strengths, weaknesses, and opportunities.
• Excellent interpersonal skills- Collaborate cross functionally; Efficiently direct and coordinate the work of others; Build an engaged culture; Foster mentoring; Provide productive feedback.

This job description is intended to describe the general nature and level of work performed. It is not an exhaustive list of all responsibilities, duties, and skills required. Duties and responsibilities may be amended as business needs evolve.

Additional Info:

The annualized base salary range for this role is $119,300 to $186,600 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic’s employees are subject to third-party COVID-19 vaccination requirements, including from customers and governmental entities. Hologic is an equal opportunity employer and consistent with federal, state, and local requirements, will consider requests for reasonable accommodation based on disability or sincerely-held religious beliefs where it is able to do so without undue hardship to the company.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

Marlborough, MA, United States, US, MA Employee