Position Description:

The SetPoint Medical Product Development team is seeking an experienced and highly motivated

individual who will be responsible for eliciting and documenting requirements for the

software, firmware, and electromechanical components of its medical device system. This

system includes not only devices intended for commercial distribution, but also test stations

and other tools used in the development of the commercial devices. The individual in this

position must take a lead role in eliciting and writing requirements at the user level and then

drilling down to the component level. They must be comfortable with writing test plans,

executing test cases, and writing test reports. Overall, the work of this individual will help to

ensure the release of a high quality product that goes well beyond meeting the bare minimum

objectives.

Job Responsibilities:

• Document user-, system- and component-level requirements that are complete, clear,

concise, implementable, and testable

• Document underlying business rules, assumptions, and constraints

• Document the rationale behind individual requirement and design decisions

• Track and disseminate requirements to provide guidelines to developers and testers

• Assist with writing test plans with an eye towards ease of traceability and comprehensive

coverage

• Assist with executing test cases and writing test reports

• Establish and maintain guidelines for documentation of requirements and test plans

Minimum Qualifications:

• BS in Engineering or an equivalent field

• 3-5 years business analysis in a technology environment

• Exemplary written and oral communication skills

• Critical attention to detail, with pride in work output

• Strong analytical skills

• Ability to communicate effectively with individuals across multiple disciplines, including

Engineering, Regulatory, Clinical, and Quality Assurance

• Ability to take basic feedback and guidance and then work independently to produce high

quality documents

• Technical proclivity to learn new systems and technology

Preferred Qualifications:

• Experience with regulated, Class III medical device or medical technology development

• Experience with software development lifecycle

• Experience with 21 CFR 820, IEC 62304, or other quality system standards

Relocation:

Not Available

Location:

Company Headquarters in Valencia, CA

Please address all inquiries to [email protected].