Sr. Software Quality Engineer at Fresenius Medical Care

Lawrence, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor’s Degree required in Computer Science, Software Engineering, or related field; Advanced Degree desirable
Solid experience in software engineering, information technology, or software quality assurance in a regulated environment
Understanding of Agile methodology (desired but not required)
Thorough understanding of regulations such as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, FDA and MDCG guidance
Expertise as Subject Matter Expert in cybersecurity and data privacy for global PD products

Responsibilities

Act as Quality Business Partner for Software as a Medical Device and Non-medical software device engineering teams to ensure compliant products, support teams with value-added mindset, and perform Post Market Surveillance activities
Work as part of software development team on new product development or design changes to ensure product quality, minimize risk to users/patients, and comply with regulatory and corporate SOPs
Review and approve design control deliverables along the product development process and design changes
Partner with/guide software project teams to ensure compliance with procedures and regulations (e.g., 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, FDA/MDCG guidance)
Plan and implement risk management, create/update risk analysis per relevant standards
Specify risk reduction measures (requirement management)
Ensure risk management activities follow the risk management plan
Assess acceptability of cybersecurity residual risks
Participate in product roadmap planning for cybersecurity measures
Evaluate post-market surveillance events (complaints/incidents) and coordinate vulnerability management/cybersecurity activities
Contribute to defining policies, SOPs, and guidelines for cybersecurity and data privacy
Compile, maintain, and evolve approved project deliverables
Communicate project/compliance issues to Quality Systems management and provide risk solutions
Develop and manage internal/external regulatory audits/inspections, presenting/defending software projects as SME
Follow all policies, guidelines, SOPs, Code of Business Conduct, company policies, and applicable laws/regulations
Work on diverse problems requiring data analysis, good judgment in methods/techniques
Network with senior internal/external personnel in area of expertise
Escalate issues to supervisor/manager as necessary
Assist with various duties/projects as assigned by direct supervisor
Focus on one or more departments/locations as per addendum

Skills

IEC62304

IEC81001-5-1

21CFR820.30

Risk Management

Cybersecurity

Data Privacy

Design Control

Requirement Management

Post Market Surveillance

FDA Guidance

Fresenius Medical Care

Provides dialysis and renal healthcare services

About Fresenius Medical Care

Fresenius Medical Care North America focuses on delivering high-quality healthcare services to individuals with kidney and other chronic conditions. The company operates a vast network of dialysis centers and outpatient labs for cardiac and vascular care, ensuring coordinated treatment for many patients across the continent. It stands out as the largest fully integrated renal company, providing not only dialysis services but also specialty pharmacy and laboratory services. Additionally, Fresenius manufactures and distributes a wide range of dialysis equipment, disposable products, and renal pharmaceuticals. The goal of Fresenius Medical Care is to enhance the quality of life for patients with chronic illnesses by providing comprehensive and accessible healthcare solutions.

Waltham, MassachusettsHeadquarters

1996Year Founded

$39.1MTotal Funding

LATE_VCCompany Stage

Biotechnology, HealthcareIndustries

11-50Employees

Benefits

Professional Development Budget

Conference Attendance Budget

Flexible Work Hours

Risks

Increased competition from telehealth solutions like Philips' eCareManager 4.1.

Rising mental health challenges may impact FMCNA's employee productivity.

Virtual reality education may face adoption and accessibility challenges in rural areas.

Differentiation

FMCNA is the world's largest fully integrated renal company.

FMCNA offers a comprehensive line of dialysis equipment and renal pharmaceuticals.

FMCNA provides coordinated healthcare services at pivotal care points for chronic conditions.

Upsides

Telehealth market growth supports FMCNA's remote patient monitoring services.

Home dialysis market expansion aligns with FMCNA's patient-centric care approach.

AI integration enhances FMCNA's predictive analytics and personalized medicine capabilities.

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