Job Description

As a member of Penumbra's Quality Assurance team, you will ensure that our software is developed according to our design control practices and meet the requirements of our internal procedures. You will be responsible for the management of all software development life cycle (SDLC) activities associated with the virtual reality product software. You will be coordinating with software design groups on the creation of software design history file documents, executing software design verification and validation (V&V) testing, supporting the rollout of product software, and supporting post market quality system activities such as complaints, non-conformance reports (NCRs), corrective and preventative actions (CAPAs), and supporting internal and external audits as needed.

What You'll Work On

• Manage and coordinate the generation and revision of software design history file documents to support software updates to the virtual reality product software.
• Create, maintain, and execute software design V&V testing in support of virtual reality product software.
• Oversee and assist with the rollout of virtual reality product software to the internal development virtual reality systems, to the manufacturing line, and to the end users.
• Provide expertise on software generation and maintenance in support of new medical devices that incorporate software.
• Act as SME on ECOs related to software validations and software change management.
• Support post market quality system activities (e.g., complaints, NCR, CAPA).
• Consider input from multiple sources/functions; leads and supports projects for improvements to the Quality System, in order to ensure product quality standards and quality system requirements are met
• Use strong communication, presentation, and influential management skills to work effectively across functions as a model and champion for quality.

What You Bring

• A Bachelor's degree of Science and 2-5+ years of quality systems experience in the medical device, pharmaceutical, or other regulated industry, or equivalent combination of education and experience
• A passion for problem solving
• Excellent oral, written, and interpersonal communication skills
• Technical writing proficiency (e.g., protocols, analytical reports, ECOs, SOPs, Work Instructions).
• Understanding of FDA regulations, ISO 13485:2016, IEC 62304, and ISO 14971 desired.
• Experience working with a variety of quality and process improvement tools required.
• Project management skills desired.
• Experience in software development and validation preferable.

What We Offer

• A collaborative teamwork environment where learning is constant and performance is rewarded.
• The opportunity to be part of the team whose technology is revolutionizing the treatment of some of the world's most devastating diseases.
• A generous benefits package that includes medical, dental, vision, and life insurance; a 401(k) match; and an Employee Stock Purchase Plan.