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Jobs at MedAcuity (Now Hiring) — 2 open

MedAcuity logoMedAcuity

SENIOR QUALITY ENGINEER

Westford, Massachusetts, United States · Hybrid

$120k–$135k/yr

Senior+

COMPANY OVERVIEW We are MedAcuity, Inc. We partner with leading product development companies to develop life and mission-critical software bringing the highest levels of Service and Value to every engagement. Through ou…

Skills: Software Verification, Test Plan Development, Defect Tracking, Risk Management, Technical Writing

MedAcuity logoMedAcuity

Senior Embedded Software Engineer

Westford, Massachusetts, United States · Hybrid

$128k–$170k/yr

Senior+

At MedAcuity, we work at the intersection of healthcare, technology and innovation in partnership with MedTech companies and innovators to develop software-driven medical devices, robotic technology, embedded systems, an…

Skills: C, C++, RTOS, Linux, Windows

MedAcuity logo

SENIOR QUALITY ENGINEER

MedAcuity

Westford, Massachusetts, United States • Hybrid

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Senior+

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  • $120k–$135k/yr
  • Full-time
  • bachelor degree
  • Medical Insurance, Dental Insurance, Vision Insurance, Health Reimbursement Arrangement (HRA), Flexible Spending Accounts, 401(k) With Company Match
  • Posted 6d ago
  • ~40 hrs/week

Responsibilities

The role involves developing and executing test plans and scripts to ensure the quality and regulatory compliance of medical device software. Responsibilities include performing data analysis, managing defect reports, and collaborating cross-functionally to identify risk control measures.

Requirements

Candidates need 8+ years of experience in software quality engineering with deep knowledge of medical device standards like ISO 13485 and IEC 62304. A Bachelor's degree in Computer Science or a related field is required or equivalent professional experience.

Full job description

COMPANY OVERVIEW

We are MedAcuity, Inc. We partner with leading product development companies to develop life and mission-critical software bringing the highest levels of Service and Value to every engagement. Through our consulting and development engagements, we bring the best and brightest talent to our clients, applying deep technical knowledge, business acumen, and innovative solutions to complex engineering problems and constructing aligned solutions for our clients. Our approach forges long-term, collaborative relationships with clients enabling them to focus on their own core competencies in Medical Devices, Robotics, and Aerospace / Defense Equipment.

JOB SUMMARY

We seek a passionate and seasoned Senior Software Quality Engineer who is interested in playing a key role in the cutting edge MedTech space. The Senior Quality Engineer enjoys working closely and cross-functionally throughout the full life cycle of projects with both internal and external constituents, including clients. The successful candidate is experienced in executing quality strategies throughout the software development lifecycle in collaboration with Software Development, Product Management, UX / UI Design, DevOps, and Regulatory / Quality teams. They will be responsible for ensuring the quality, reliability, performance, and regulatory compliance of regulated medical device software.

Together, we’re pioneering the future of science by developing software products and solutions that enable our partner teams to help save lives.

RESPONSIBILITIES

  • Develop and execute test plans, test cases, and test scripts.

  • Contribute to software verification plans, perform data and performance analysis, and writing of final reports, including test summary reports and defect justifications.

  • Generate defect reports and verify correct technical fixes while also investigating / isolating root cause of defects and leading triage meetings.

  • Develop and implement quality metrics associated with software development and testing performance.

  • Assess and evaluate new tools and testing methodologies in addition to leading tool validation efforts.

  • Analyze architecture and designs to identify test strategies to provide full test coverage.

  • Participate in analysis and refinement of requirements for testability, gaps, and clarity.

  • Identify risk management activities to ensure software risk control measures are identified and verified; assist with risk-related documentation, if necessary.

  • Abide by and ensure compliance with MedAcuity’s policies, including Information Security and Quality Management Systems.

QUALIFICATIONS

  • 8+ years of experience with relevant and recent expertise performing the same or similar type of work as required by the position in compliance with the recognized standards below:

    • Strong working knowledge of the requirements of FDA QSRs, ISO 13485, IEC 62304, IEC 60601 and ISO14971.

  • Experience supporting medical device development and production release cycles.

  • Professional background working in Agile / Scrum development environments.

  • Expertise with defect tracking and metrics.

  • Hands-on experience with requirements management software such as Helix ALM, Jama or Doors.

  • Strong technical writing skills, including development of test methods, protocols, reports.

  • Proficient computer skills with applicable software packages such as Microsoft Office, Matlab, Excel, etc.

PREFERRED SKILLS

  • Possess a complete understanding of software development lifecycle phases.

  • Strong analytical and troubleshooting skills.

  • Excellent written and verbal communication.

  • Risk-based decision making.

  • Quality mindset with attention to detail.

  • Ability to influence cross-functional teams.

EDUCATION

  • Bachelor’s Degree in Computer Science or a related discipline OR equivalent years of experience in a comparable role.

A realistic estimate of starting base salary for this this full-time position is $120,000 to $135,000. The actual salary offered may vary based on work location, experience, education, training, external market data, internal pay equity and other business considerations. This position qualifies for a discretionary performance based bonus based on personal and company factors. We also offer a comprehensive benefit program including medical, dental and vision insurance, a Health Reimbursement Arrangement (HRA), Flexible Spending Accounts, 401(k) with company match, company paid life and disability insurance, additional voluntary life insurance, employee assistance programs and recognition awards. Our leave programs include competitive vacation and sick time allowances, company holidays, and a healthy work life balance is a priority here.

Applicants for employment at MedAcuity, LLC are considered without regard to race, color, religion, sex, sexual orientation, gender-related identity/appearance, pregnancy, age, genetic information, national origin, status as a Vietnam Era or disabled veteran or membership in the uniformed services, physical or mental disability, or any other legally-protected classification.

MedAcuity is an equal opportunity employer.

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Related keywords

MedTechMedical DevicesSoftware Quality EngineeringFDA QSRISO 13485IEC 62304IEC 60601ISO 14971AgileScrumHelix ALMJamaDoorsMatlabSoftware Development LifecycleVerification and Validation

About MedAcuity

LinkedInVisit site

Accelerating MedTech Innovation. Ask Us How!

Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2007
Headquarters
Westford, Massachusetts
LinkedIn followers
3,407

MedAcuity, a software engineering firm, partners with companies to address the business and technical challenges inherent in developing complex software-intensive solutions. Offering a combination of strategic consulting services focused on aligning product technology strategy with business goals and full lifecycle software development expertise, we accelerate the pace of innovation for leading companies and innovators in the MedTech, Life Sciences and Robotics industries. With over a decade of experience in software design and development methodologies for highly regulated and compliance-driven environments, our technical capabilities span all levels of software from embedded systems to mobile devices, the cloud and enterprise technologies. ISO 13485:2016 & ISO 27001:2013 Certified IEC 62304 and ISO 14971 Compliant

Offices: 210 Littleton Rd, Westford, Massachusetts 01886, US

Project turnaroundsFull SDLCArchitecture AssessmentData Privacy and SecurityOrganizational AssessmentDevelopment Process MethodologyRisk ManagementQMSProduct Development510k Submission Readiness
View all jobs at MedAcuity

About MedAcuity

LinkedInVisit site

Accelerating MedTech Innovation. Ask Us How!

Industry
Medical Equipment Manufacturing
Company size
51-200 employees
Founded
2007
Headquarters
Westford, Massachusetts
LinkedIn followers
3,407

MedAcuity, a software engineering firm, partners with companies to address the business and technical challenges inherent in developing complex software-intensive solutions. Offering a combination of strategic consulting services focused on aligning product technology strategy with business goals and full lifecycle software development expertise, we accelerate the pace of innovation for leading companies and innovators in the MedTech, Life Sciences and Robotics industries. With over a decade of experience in software design and development methodologies for highly regulated and compliance-driven environments, our technical capabilities span all levels of software from embedded systems to mobile devices, the cloud and enterprise technologies. ISO 13485:2016 & ISO 27001:2013 Certified IEC 62304 and ISO 14971 Compliant

Offices: 210 Littleton Rd, Westford, Massachusetts 01886, US

Project turnaroundsFull SDLCArchitecture AssessmentData Privacy and SecurityOrganizational AssessmentDevelopment Process MethodologyRisk ManagementQMSProduct Development510k Submission Readiness
View all jobs at MedAcuity

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