Software Design Control Engineer

Software Design Control Engineer

SUNNYVALE CA

ONSITE

12MONTHS

Description:
IMPORTANT: Suppliers should not submit workers whose physical residence is within the following states due to Intuitive tax and operating entity structure:
Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.
Please interpret this as Intuitive policy to which all suppliers are required to comply.

As a Software Design Control Engineer, you will be responsible for delivering technical documentation to support projects with minimal impact on resources while ensuring operational effectiveness. You will work within the Multiport software team and collaborate closely with Design and Product Engineering, Quality, and Document Control teams. Key responsibilities include:
Developing, executing, maintaining, and supporting design control infrastructure (risks/FMEAs, requirements, etc.).
Generating trace reports, identifying, and resolving gaps through collaboration with various departments.
Informing design decisions based on documented product risk and design control strategy.
Supporting the Multiport team in creating trace, requirement, test protocol/report, TLTR, Known Anomaly List documents for regulatory submissions and software releases.
Experience/Skill/Job Requirements:
BS degree in engineering discipline, or equivalent

5+ years industry experience
Medical device experience
Familiarity with design controls risks, trace reports, design controls
Strong writing and grammar skills in areas of content development and writing style. Analytical ability to swiftly grasp and effectively communicate complex technical engineering concepts.
Excellent written and verbal communication skills with a proven ability to present information in a clear and concise manner to various technical, business stakeholder, and leadership audiences
Preferred Qualifications and Skills:
While the candidate is expected to have some of the following skills, a strong propensity for learning and the ability to synthesize new information effectively will be highly valued:


Experience creating or modifying risks, trace reports, functional requirements, etc.
Knowledge of medical device regulations, both US and OUS (e.g., FDA regulations, MDR, China PTR, etc.).
Experience working with design control software (MKS, Polarion, etc.).
Strong organizational skills and the ability to manage deliverables under tight deadlines, set priorities, and manage time effectively.
Team player with the ability to interface with technical SMEs and business stakeholders across multiple disciplines to achieve the best outcomes.
Ability to quickly learn new tools, drive process improvement, and manage change.
Demonstrated ability to understand, resolve, and communicate technical and business issues.
Organized and detail-oriented, with a high level of integrity and reliability.
Excellent analytical and problem-solving skills with attention to detail; mission-critical production support experience.
Solid foundation in system engineering principles such as requirements definition, system integration, formal verification, and validation methods.

We look forward to welcoming a dedicated and skilled professional to our team who is passionate about contributing to the success of our projects and the advancement of our technology.