Job Description
Title: Software Design Quality Engineer
Location: Westford, MA 01886
Duration: 12 Months
What You ll Do:
Requirements
Education And Experience You ll Bring
Location: Westford, MA 01886
Duration: 12 Months
What You ll Do:
- Lead, execute and support on-time completion of Quality Engineering deliverables from product concept through commercialization, including but not limited to risk management activities (RMF, FMEA)
- Support on-time execution of Quality Plans
- Guide development and documentation of standard operating procedures, specifications and test procedures
- Support product recertifications
- CAPA management including (but not limited to) performing thorough investigations with detailed root-cause analyses with established methods (Fishbone, 5 Why), implementing corrections, corrective actions, creating and monitoring effectiveness criteria.
- Work within Agile software development lifecycle framework
- Support usability and human factors engineering reviews
- Participate in reviews for System and Software requirements, Software and Firmware design, and code inspection
- Review and approve test methods, protocols and test results provided by another functional group.
- Support activities related to software change management and overall change management
- Support all activities, as needed by the business within the software development lifecycle.
- Ensure DHF content completion, integrity, and regulatory & standards compliance;collaboratively communicating & resolving gaps
- Support internal & external audit and related responses
- Support the establishment of objective, measurable and verifiable customer and product requirements
- Complete document Change Request reviews in a timely and objective manner
- Additional duties may be identified by functional management based on the current project/business objectives.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintain positive, cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Perform other related duties and responsibilities, on occasion, as assigned.
Requirements
Education And Experience You ll Bring
- Bachelor level degree in Computer science, biomedical engineering, software engineering or a closely related discipline or an equivalent combination of education and work experience.
- Minimum of 2-5+ years of combined experience in software design quality, cybersecurity design quality
- Experience ensuring automation frameworks and scripts meet design control requirements
- Experience with software configuration, and issue tracking tools and requirements tools such as Jira and Jama
- Experience as team-member/lead in Agile SDLC projects/programs
- Deep knowledge of various types of SDLC s (V-Model, Iterative, Agile/Scrum, etc.)
- Experience working in a broader enterprise/cross-site business unit model
- Working knowledge of GMP, 21 CFR part 820, IEC 62304, ISO 14971, and ISO 13485
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment
- Ability to work in a lab, and hands-on experience with medical device development
- Ability to leverage and/or engage others to accomplish projects
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
- Ability to multitask, prioritize and meet deadlines in timely manner
- Strong organizational and follow-up skills, as well as attention to detail
- Master s level degree preferred
- ASQ CSQE and ISTQB certifications desired
- Experience working with test management tools such TestComplete, desired
- Experience in code review/static analysis tool(s) to aide code review such as Coverity, desired
- Programming experience in C/C#/Visual Studio/Java, Scripting Language such as Python, Ruby, Perl, desired
- Clinical/Hospital experience desired
- Experience in software testing and verification/validation, desired
Numbers & Facts
| Location | Westford, MA |
| Industry | Staffing/Employment Agencies |
| Salary | $43.33 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Agile Programming Methodologiesunmatched
- American Society for Quality (ASQ)unmatched
- Atlassian JIRAunmatched
- Biomedical Engineeringunmatched
- Business Modelunmatched
- C Programming Languageunmatched
- Change Managementunmatched
- Change Requests/Ordersunmatched
- Code Reviewsunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Computer Firmwareunmatched
- Computer Scienceunmatched
- Corporate Policiesunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Detail Orientedunmatched
- Documentation Standardsunmatched
- Environmental Management Systemsunmatched
- Establish Prioritiesunmatched
- External Auditunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- Follow Throughunmatched
- GMP (Good Manufacturing Practices)unmatched
- Hospitalunmatched
- Human Factorsunmatched
- ISO (International Organization for Standardization)unmatched
- ISTQB Foundationunmatched
- Internal Auditunmatched
- International Electro-Technical Commission (IEC)unmatched
- Internet Securityunmatched
- Javaunmatched
- Medical Equipmentunmatched
- Microsoft C# (C Sharp)unmatched
- Microsoft Visual Studiounmatched
- Multitaskingunmatched
- Operations Processesunmatched
- Organizational Skillsunmatched
- Perl Programming Languageunmatched
- Presentation/Verbal Skillsunmatched
- Product Supportunmatched
- Product/Service Launchunmatched
- Python Programming/Scripting Languageunmatched
- Quality Assurance Methodologyunmatched
- Quality Engineeringunmatched
- Quality Managementunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Rubyunmatched
- Scripting (Scripting Languages)unmatched
- Scrum Project Management and Software Developmentunmatched
- Software Configuration Managementunmatched
- Software Designunmatched
- Software Development Lifecycle (SDLC)unmatched
- Software Engineeringunmatched
- Software Testingunmatched
- Standard Operating Procedures (SOP)unmatched
- Standards Developmentunmatched
- Static Analysisunmatched
- Technical/Engineering Designunmatched
- Test Toolsunmatched
- Testingunmatched
- Time Managementunmatched
- Usability Engineeringunmatched
- Validation Testingunmatched
- Writing Skillsunmatched
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