JOB SUMMARY
Designs and develops staining procedures in close collaboration with assay development. Develops software supplements that install staining procedures along with the underlying database elements required to the support staining procedure(s) in the software application. Delivers projects on time in a fast paced environment. Mentored on the use of software tools and editing staining procedures. Monitors work to ensure quality, and continuously promote Quality First Time.
Responsibilities
* Develops moderate scoped procedures, with guidance from more senior engineers, to ensure optimal compatibility across platforms, as well as efficient performance on an instrument.
* Executes both manual and automated test scripts.
* Learns company concepts, policies and procedures, familiar with and follows Product Development Process (PDP) and Work Instructions (WIs).
* Creates and tracks documentation deliverables according to the PDP and Work Instructions. Identifies the correct reviewers and approvers for various document deliverable types.
* Manages Design Change Orders (DCOs), Document Changes (DCs), and Product Development Process Document Approvals (PDP DAs) via the Document Control System (DCS).
* Manages and maintains the Software Design History File (DHF) in the DCS. Creates and organizes documentation deliverables per best practices.
* Creates and delivers presentations for project review meetings. Records meeting minutes, decisions, and action items. Drives action item completion.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each responsibility satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the responsibilities.
Formal Training/Education
BS degree in a similar field such as Computer Science, System Engineering, Bio-Medical Engineering, etc,
4 years in a directly related discipline, or,
Equivalent combination of education and experience, with 2 years of experience for each year of education. - REQUIRED
Experience
2 years related experience - PREFERRED
2 years experience in a regulated industry - PREFERRED
Equivalent combination of education and experience, with three years of experience for each year of education.
Knowledge, Skills and Abilities
* Basic organizational skills and ability to manage multiple concurrent projects. - REQUIRED
* Ability to plan project components and effectively report status to stakeholders. - REQUIRED
* Knowledge of creating software documentation for a medical device. - REQUIRED
* Knowledge of software databases such as SQLite - REQUIRED
* Knowledge of scripting languages such as Python or Delphi - REQUIRED
* Skilled with use of word processing, spreadsheets, graphical and presentation software applications - REQUIRED
* Ability to create project documentation that is complete, consistent, and useable. - REQUIRED
* Proficient in a document control system(s) (such as Agile). - REQUIRED
* Strong written and verbal communication skills. - REQUIRED
* Understanding or familiarity with project management tools (such as Smart Sheets, MS Project, or Trello). - REQUIRED
* Ability to create/edit written procedures and document work accurately. - REQUIRED
* Ability to meet deadlines and deliver projects on time. - REQUIRED
* Information Security and Data Privacy fundamentals - REQUIRED
Travel Requirements - Based on business needs
EEO Statement Apollo Professional Solutions, Inc. is an equal opportunity employer. We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, marital status, age, national origin, ancestry, disability status, medical condition, pregnancy, genetic information, protected veteran status, gender, sexual orientation, gender identity or expression, or any other status or characteristic protected under federal, state, or local law.
