Engineer Jobs

About The Position

Requirements

• Bachelor's degree in Engineering, Science, or a technical field and at least 4 years of relevant experience in Quality, Engineering, and/or Software Development; or an advanced degree in one of these fields and at least 2 years of relevant experience.
• Working knowledge of medical device compliance standards, including IEC 62304, ISO 13485, ISO 14971, and FDA QMSR.
• Ability to author technical reports, business correspondence, and standard operating procedures.

Nice To Haves

• Experience with software design and development, verification, validation, and testing for mobile applications, web applications, and/or cloud infrastructure services such as Amazon AWS or Microsoft Azure.
• Experience working in an SDLC environment using ALM tools such as PTC Integrity, Atlassian Suite, or TFS, and defect tracking tools such as Jira or PTC.
• Exposure to wireless communication protocols such as Bluetooth.
• Working knowledge of integrated digital health systems, including consumer products such as Apple and Android products.
• CQE or CSQE certification.

Responsibilities

• Serve as a quality core team member and drive quality into the design and development of digital health solutions, collaborating with R&D, Regulatory, Marketing, and Operations.
• Develop collaborative quality strategies for projects in alignment with business goals.
• Provide quality oversight and evaluate software lifecycle activities across requirements, design, development, documentation, integration, testing, verification, and validation.
• Participate in design reviews and review and approve design inputs and outputs, including requirements, design documents, test results, verification and validation reports, and defects.
• Ensure project and process control documentation complies with procedural requirements, applicable standards, and regulations, with full requirements traceability maintained.
• Lead and conduct risk management activities, including system risk analysis and software FMEAs.
• Manage and triage software issues with cross-functional teams.
• Develop, modify, apply, and maintain standards, methods, processes, and procedures for software systems quality.
• Develop operating criteria to ensure implementation of the software quality program according to project, process, requirements, and objectives.
• Lead and drive CAPA projects and quality improvement projects, including compliance standards for software quality methods, processes, and procedures.
• Participate in internal and external regulatory audits and inspections.
• Participate in and support Quality Management System reviews of Standard Operating Procedures aligned with U.S. and international standards.
• Support the post-market team for FCAs or HRAs as needed.

Benefits

• Competitive salary and flexible benefits package.
• Health insurance.
• Dental insurance.
• Vision insurance.
• Health Savings Account access.
• Healthcare Flexible Spending Account access.
• Life insurance.
• Long-term disability leave.
• Dependent daycare spending account.
• Incentive plans, including eligibility for a Short Term Incentive (STI).
• 401(k) plan with company match.
• Short-term disability coverage.
• Paid time off and holidays.
• Employee Stock Purchase Plan participation.
• Employee Assistance Program access.
• Eligible employees may have access to a Non-qualified Retirement Plan Supplement and Capital Accumulation Plan, subject to IRS minimum earnings requirements.