ABOUT FOUNDATION MEDICINE
Foundation Medicine, Inc. (FMI) began with an ideato simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
ABOUT THE JOB
The Senior Manager of Software Quality Assurance ensures best practices in place for software engineering through supervision, development, coaching and evaluation of personnel and through maintaining and developing QA procedures. The position assesses emerging technologies and determines how to map these into Product Development roadmaps. Additionally managing Software Test Engineering, the incumbent ensures compliance with product lifecycle and development procedures and processes as well as all applicable quality and regulatory requirements. Primarily this position coaches, mentors, and develop system test engineers, including Software Development Engineers in Test and Manual Software Quality Assurance Engineers, in the use of automation and manual test tools and methodologies to develop and execute test protocols.
Implement and monitor structured system testingautomated and manualstrategies and methodologies. Automation testing is primary.
Collaborate with cross functional teams to employ iterative development test strategies and tactics on assigned projects and ensure full execution of the strategy.
Adapt process and procedures according to business process change.
Identify common trends on planned estimated effort hours vs actual hours.
Manage system test activities, provide test effort estimates, create and maintain test metrics.
Manage, review and optimize test design, reusable test cases and test procedures to ensure complete functional and non-functional test coverage for multiple projects concurrently.
Define and measure key progress indicators on requirement coverage, test case effectiveness, Test execution and defect identification and closure.
Develop the team's objectives, policies and processes on short and long term, makes sure that the organization can meet the objectives and ensures that the roles and responsibilities are put in place.
Manage the capabilities of the team to develop and maintain a long-term view on the required competences and knowledge to introduce new technology.
Manage a team to ensure the effective leveraging of talent and execute performance management activities to continually improve the talent base.
Create and maintain a positive and engaging culture within the R&D function, and ensure strong cross-functional collaborating with other functions within Process Engineering.
Deliver new releases to the business on time with highest quality.
Achieve operational plans, guiding Project Managers/Leaders and ensuring the optimal allocation of personnel to the projects and effective project management.
Ensure team compliance with design controls and FMI Software Development Lifecycle and Maintenance procedures.
Ensure all employees adhere to all applicable cGMPs, ISO, FDA, corporate, division and local procedures.
Other duties as assigned.
Advanced Degree in Computer Science, Computer Engineering or related Engineering field.
8+ years of experience in the medical device or biotechnology industry.
2+ years' experience managing a global systems test engineering team.
Successful record of accomplishment leading people, executing complex new product development projects / programs / improvement opportunities (timelines, quality, capacity, capability, cost, productivity, etc.).
Strong leadership skills (change management, communications, building rapport and executing within a complex matrixed global organization).
Effectively communicates to numerous stakeholders including senior management, other Business Groups, internal and/or external customers and staff.
Experience in the use of system test engineering tools test protocol management system, defect tracking system, automation tools.
Familiarity with Medical Development regulations as in FDA 21 CFR part 820, CFR 21 part 11, ISO 13485, ISO 14791, IEC 52304, The Medical Device Directive, and Safety as in EN60601-1.
Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues.
Understanding of HIPAA and importance of privacy of patient data.
Excellent organization and attention to detail.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement. If you have a disability or special need that requires accommodation, please let us know by completing this form. (EOE/AAP Employer)