Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
- Job Title: Senior Systems V&V Engineer
Department: Systems Engineering COE
FLSA Status: Exempt
Position Overview: The Senior Systems V&V Engineer will be a technical expert responsible for leading Systems Engineering activities related to Verification and Validation of Insulet’s products.
The position will report to the Systems Design Verification Manager, located at Insulet’s Headquarters in Acton, MA.
Responsibilities: - Manage all Verification and Validation activities and deliverables for New Product Development and sustaining products
- Provide technical leadership for System Design Verification team.
- Lead initiatives to advance processes and tools related to Design Verification activities according to System Engineering COE department objectives
- Leads the development and execution of system integration, system verification and regression plan.
- Develop, review, implement and maintain test strategies, test protocols, test cases, test reports and traceabiity matrices for system verification.
- Report defects found during testing and assist in root cause analysis.
- Drive the impact analysis and effort estimates
- Collaborate with Systems Engineering to ensure that requirements are testable and appropriately leveled for verification with component level test teams (HW/SW)
- Co-ordinate with project managers, system engineers and other technical leads to plan and execute project goals
- Work closely with System Automation Test team to optimize test coverage and test execution strategy
- Define, track and report KPIs for product verification and product quality
- Mentor to junior team members on topics such as sample size justification, statistical analysis, risk-based test coverage optimization
- Manage and track product configurations including hardware, software, firmware version tracking and determine the impact due to configuration changes for System Design Verification
- Ensure compliance with regulatory standards and Insulet quality policies, procedures and practices
Education and Experience:
Minimum Requirements:
- Bachelors’ Degree in Biomedical Engineering or a related field.
- Minimum of 5 years’ experience testing medical devices in a multidisciplinary project team environment or advanced degree and 2+ years of experience
Preferred Skills and Competencies:
- Strong technical judgement with extensive technical leadership skills
- Demonstrated capability of leading System design verification for programs on an electromechanical device
- Excellent Program Management Skills – PMP Certification a plus
- Experience working in an Agile based Software Development environment preferred.
- Experience guiding team/individuals to develop technical solutions to complex problems
- Sound knowledge of engineering first principals
- Strong Analytical and Problem-Solving Skills
- Ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams
- Good written and verbal communication skills
- Familiarity with medical device System Level Testing
- Test Engineering training and/or certification is a plus
- Experience working with requirements management tool (Helix, Jama, Polarion), quality management system, test case management tool, defect management tool is preferred
- Demonstrated skills developing and introducing innovative FDA-regulated medical devices (Class 2 or 3) under Design Controls
- Experience with design and development processes that conform to standards such as ISO 13485, IEC 62304, IEC 60601, and ISO 14971
Physical Requirements (if applicable):
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid
Additional Information:
The US base salary range for this full-time position is $92,700.00 - $139,050.00. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.
At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.