Software Program Manager
Palo Alto, California
Employment Type: Full Time
To apply for this job, please email us your resume at firstname.lastname@example.org
Job Description / Requirements
The Program Manager will be instrumental in dictating the software documentation and development process, ensuring that it adheres to company-defined standards. You will act as the liaison between the Product Management, Software, Quality Assurance, and Regulatory Teams. We are seeking individuals who are ready for a challenge and are driven to meet the needs of our patients and growing business.
- Manage high-level documentation processes and drive teams to follow such processes.
- Administer design control software utilized in the documentation and development process.
- Review and approve software system validations and changes.
- Assist in the creation and review of content such as requirements documents, test plans, risk assessments, hazard analyses, etc.
- Generate, review and/or maintain records or documents in a detailed and consistent manner.
- Participate in the planning, execution and follow up on internal and external quality audits.
- Ensure compliance with applicable State and Federal regulations and Company Policies, Procedures, Goals and Objectives.
- Train various team members on internal Quality Management policies.
- Coordinate and manage continuous improvement projects.
- Own deviation and change control records.
- Bachelor's Degree from a top-tier university.
- 5+ years of professional work experience in software product/program management, compliance management, or information technology.
- Experience with validation of software/IT systems in a regulated industry such as medical devices or financial services.
- Working knowledge of the development of protocols for the validation of complex computer systems.
- Knowledge of all phases of the product development life cycle including design, implementation, debugging, verification, qualification, and production support.
- Strong presentation and communication skills required.
- Experience with Quality Systems Standards (ISO13485, FDA CFR 21 Part 820 and Part 11) highly desired.
- Experience with software verification and validation of medical device software desired.
- Experience with Laboratory Automation Systems (LIMS/LIS) a plus.
- Demonstrated high level of initiative and ability to function superbly in both individual and team environments.
- Ability to work in a complex and fast moving environment and handle stressful situations and deadline pressures well.
- Some travel may be required.