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Tech Stack
Tools & technologiesTFS
About the role
Key responsibilities & impact- Perform workflow analysis, document test results and recommend quality improvements
- Work with engineers to resolve software defects and diagnose/improve product configuration for current and future models.
- Define, plan, organize and coordinate V&V activities with teams across multiple sites in accordance FDA and other regulatory requirements.
- Manage and develop software test talent within the organization and work with a cross-functional team to foster synergy in day-to-day operations.
- Lead in forecasting, effort estimation, resource & test planning, training, execution, and release activities.
- Aptitude for continuous improvement, identify and implement industry standard software test technology, methods, and tools.
- Well versed in different test development methodologies include Agile to enables breaking barriers across the organization.
- Oversee definition and implementation of different software testing techniques to increase test coverage.
Requirements
What you’ll need- Bachelor's degree and a minimum of 7 years of relevant experience with 5+ years of managerial experience OR advanced degree with a minimum of 5 years of relevant experience with 5+ years of managerial experience
- Expert knowledge of Medical Product verification, IEC- 62304 and FDA guidance in a technical discipline, preferably software related (Computer Science, Computer Engineering, Electrical Engineering)
- Thorough understanding of creating test protocols for verifying software requirements.
- Strong understanding of good documentation practices, various off the shelf test management systems
- Ability to work with QA to ensure testing meets Quality and Regulatory needs.
- Ability to manage, track and upgrade multiple hardware and software configurations.
- Ability to work with Systems, Mechanical, Electrical and Software engineers when discovering, documenting, and resolving integration issues.
- Experience using a tool or repository for managing test cases (Polarion, TFS, TestRail, JAMA etc).
- Experience debugging hardware with tools such as oscilloscope and function generators
- Experience writing technical reports
- Strong work ethic and entrepreneurial drive
- Ability to work effectively in a fast-paced, collaborative environment.
- Strong communication skills, both written and verbal.
Benefits
Comp & perks- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
workflow analysissoftware testing techniquestest protocolsdebugging hardwaretest management systemstest case managementquality improvementsregulatory compliancecontinuous improvementAgile methodologies
Soft Skills
leadershipcommunication skillscollaborationorganizational skillsentrepreneurial drivestrong work ethicresource planningtrainingeffort estimationproblem-solving
Certifications
Bachelor's degreeadvanced degree