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Senior Design Assurance Engineer I, Software
Job summary
Ein innovatives Unternehmen sucht einen erfahrenen Senior Quality Engineer, der die Qualität von Software für medizinische Geräte sicherstellt. In dieser Rolle arbeiten Sie eng mit Entwicklungsteams zusammen, um Designkontrollen und Risikomanagement zu unterstützen. Sie werden an der Entwicklung neuer Softwaredesigns mitwirken und bestehende Produkte verbessern. Das Unternehmen bietet ein dynamisches Umfeld, in dem Ihre Fähigkeiten in der Qualitätssicherung und Softwareentwicklung geschätzt werden. Wenn Sie leidenschaftlich an der Verbesserung von Produkten arbeiten möchten, ist dies Ihre Chance.
Qualifications
- 5+ Jahre Erfahrung in der Medizintechnik oder einer halbregulierten Branche.
- Starke Kenntnisse in der Softwareentwicklung und Qualitätssicherung.
Responsibilities
- Unterstützung bei der Entwicklung medizinischer Geräte mit Software.
- Überprüfung von Software-Testfällen zur Unterstützung der Designvalidierung.
Skills
Education
Tools
GLAUKOS - SR. QUALITY ENGINEER (SOFTWARE/R&D QUALITY) BURLINGTON, MA
The Senior Quality Engineer I, Software position supports the Quality Engineering (QE) team throughout the full product lifecycle of innovative ocular medical devices. Responsibilities include executing design control deliverables, risk management activities, ensuring Design History File compliance, and supporting assessment and implementation of design changes for already approved medical devices. This role involves developing new software designs and maintaining and enhancing existing products from a software perspective.
Under general managerial supervision, collaborates with development teams in the following areas:
- Support the development of medical devices with software by working with application developers and product teams.
- Assist in the development and qualification of software development tools and services.
- Review software test cases and test runs to support design verification and validation activities.
- Review Software Design Documentation.
- Participate in risk management activities to ensure effective product development and operational compliance with ISO 14971, IEC 62304, and ANSI/AAMI SW96.
- Support changes to product designs.
- Assist in engineering change order preparation and review.
- Help in periodic reviews of quality system procedures.
- Support QE CAPA owners with task follow-up.
- Assess and improve quality system processes through data monitoring and trend analysis.
- Participate in internal audits and conduct audits as needed.
Perform additional duties and projects to support R&D, Operations, Production, Engineering, Clinical, and Regulatory goals.
- Bachelor's degree required.
- 5+ years in medical device or a semi-regulated industry; 8+ years preferred.
- Strong knowledge of medical device manufacturing and software development.
- Familiarity with GMP, ISO 13485, ISO 14971, EU MDD/MDR, GDPR, 21 CFR Part 820, ISO 62304, and IEC 60601 software requirements.
- Expertise in medical product quality assurance, including test protocols and statistical techniques.
- Proficiency in programming languages such as C++, Java, or Python, and experience with software development tools like version control, bug tracking, and automated testing tools.
- Excellent documentation skills, attention to detail, and accuracy.
- Strong team player with good communication skills.
- Organized with the ability to coordinate activities across departments and vendors.
- Emerging leadership qualities demonstrated through performance and accomplishments.
- Strategic thinking and industry understanding in project execution.
- Proficient in data entry and typing skills.
- Experience with ERP systems is required.
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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