Remote or On-Site Role in New Haven, CT or Foster City, CA
Description
Adela is seeking a highly motivated and creative individual to join the Product & Program Management team. This is an exciting opportunity to be part of a growing, dynamic, and collaborative company delivering cutting-edge technology directly to clinicians. The primary function of this position will be to execute technical program strategies through collaborating with internal cross-functional teams that require a high-level of detail, organization, and planning.
The ideal candidate will be able to manage software product development and interface with highly complex and specialized internal functions, including product development, software engineering, bioinformatics, medical device regulatory and compliance, quality, and data science, among others. This individual will be a self-starter who is looking to manage the full lifecycle of complex software and biometrics projects that support the development of a medical device. This role will report to the Senior Technical Product Manager.
Responsibilities
● Manage multiple software projects using agile at various levels of maturity across a matrixed organization.
● Implement Software Development Life Cycle (SDLC) processes for medical device software to ensure best practices and adherence to safety and quality standards.
● Develop milestones and priorities to align with and support the business and product strategy.
● Collaborate with cross-functional stakeholders and subject matter experts (SMEs) to develop project plans, detailed timelines, process models, and project documentation.
● Partner with internal stakeholders and functional leads to identify and document user needs, user personas, and functional requirements.
● Manage project teams at a high-level but also have the ability to dive into the details of each project and represent the needs of the SMEs.
● Lead or moderate regular team meetings to maintain alignment with priorities, coordinate activities and document progress, risks, and decisions.
● Escalate project risks to key stakeholders and collaborate with SMEs to develop mitigation plans and corrective measures.
● Provide regular updates to the broader Product & Program Management team, highlighting key dependencies and risks to timelines, including resource constraints and scope changes.
● Represent the Product & Program Management group as a key stakeholder in cross-functional workstreams and initiatives.
● Identify and implement best practices and process improvements, and ensure adherence to ICH, GCP, and local regulations among cross-functional teams.
Preferred experience
● BS, MS preferred in Computer Science or equivalent.
● Minimum of 3-5 years of experience in technical project/product management, product development, and/or software development/informatics in a pharmaceutical, biotechnology, health-tech, or diagnostics organization.
● Proficiency in Jira, or equivalent tool, to manage agile software development.
● Familiarity with project management and software development tools such as Smartsheet and GitHub, as well as other configuration management tools.
● Project Management Professional (PMP) and/or Scrum Master (CSM) certification preferred.
● Understanding of ISO/IEC/IEEE 15288 (Systems Engineering), IEC 62304 (Software Life Cycle Processes) and FDA 21 CFR 820.30 (Design Controls).
● Experience using electronic quality management systems (eQMS), such as MediaLab.
● Experience using requirements management tools, such as Jama Connect.
● Well-developed organizational and interpersonal skills with careful attention to detail.
● Skilled at innovation, collaboration, and execution of business strategy.
● Ability to identify and resolve complex issues.
● Excellent written and verbal communication skills.