Be part of
rethinking the
future of
healthcare.

Be part of
rethinking the
future of
healthcare.

At VitalConnect, our common mission is to save lives and enhance patient care by providing elegant monitoring solutions. We invite you to come join us in making a difference.

Current Openings



Principal Software Quality Systems Engineer

Location: San Jose, CA
Date Posted: 05-02-2018
Principal Software Quality Systems Engineer

VitalConnect is delivering a revolutionary solution for in hospital and outpatient care to address the growing need for patient data connectivity. VitalConnect leverages extensive expertise in biomedical engineering, data analytics, chip design, and mobile and cloud software to create technology that supports decision-making paradigms that achieve better health and economic outcomes. VitalConnect’s products are designed for use in a broad range of inpatient and outpatient settings, such as hospital monitoring, post-discharge care, cardiac monitoring and pharmaceutical solutions.
 
We’re looking for people who are passionate about revolutionizing healthcare with digital technology. Are you a top performer looking for a dynamic atmosphere with a lot of freedom and responsibility? We want to hear from you! 

Responsibilities:
•    Provide expertise and guidance in interpreting regulations to ensure compliance of software system processes, standards, and procedures, including:
•     FDA’s Quality System Regulation (QSR), EN ISO 13485:2016, EN ISO 62304:2015, EN ISO 14971:2012, IEC 60601-1 3.1 edition Clause 14, the European Medical Device Directive (MDD), FDA Guidance’s for software, cybersecurity and other relevant standards.
•    Actively review all elements of software including design, development, and testing for commercialization of Vital Connect products through interactions with R&D, Regulatory, Clinical and Marketing departments as necessary.
•    Author, review, and hold meetings to support Software-related process and production documents, including but not limited to leading the Change Control Board.
•    Support Design History File requirements for regulatory submissions (U.S. and international); interfacing with software developers and testers.
•    Support Software Design Control and Risk Management, including the software hazard analyses, FMEA, software traceability matrices and master test plans.
•    Partner with internal colleagues to influence or plan and execute strategies for continuous improvement in processes, standards and procedures that accommodate software quality, systems and/or compliance needs.
•    Review and challenge software documentation (including requirements, design, verification, validation, test procedures) to ensure that requirements stated are correct, unambiguous, and verifiable.
•    Consult with software product development and software test to evaluate system interfaces, operational requirements, and performance requirements of overall system.
•    Responsible for conducting and/or approving software Complaint Investigations.
•    Provide quality assurance support to software related CAPAs and Non-conformities.
•    Provide quality engineering interface between Quality and R&D Software teams.
•    Conduct periodic gap analysis of current processes for compliance to standards. Revisit the gap analysis, updating as necessary to changing standards and regulations.
•    A demonstrated history of providing “added value" to the product development process as opposed to functioning in a “quality police” environment.  
 
Desired Skills and Experience
Qualifications:

•    BS in Computer Science, Computer Engineering, or related Engineering degree. MS, MEng, and PhD degrees in relevant engineering disciplines are highly preferred.
•    Minimum of 9 years’ experience in new medical device product development with at least 3 years focused on quality engineering related activities. Certified Software Quality Engineering – ASQ certification preferred.  
•    Class II medical device and active experience preferred. 

Benefits at VCI include:
•    Employee Medical, Dental, and Vision benefits paid 100% by Vital Connect for employee and dependents!
•    Pre IPO Stock
•    Annual holiday shutdown from Christmas to New Years!
•    Lunch catered daily (TOGO's, Premier Pizza, Subway, Gotta Eatta Pitta, Rangoli India, Panda Express, BBQ, and many more!)
•    Morning snacks provided (Hi5 Fruit, Whole Foods, Noah's Bagels, Hobee's)
•    Free on-site gym
this job portal is powered by CATS