Program Manager

Company: Otsuka Pharmaceutical Co., Ltd
Location: Palo Alto
Posted on: April 1, 2025

Job Description:

At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise uRDN System, we're on a mission to provide the millions of people who suffer from hypertension with a non-drug and minimally invasive option to lower their blood pressure. Join us on our journey and make a meaningful impact on the lives of people around the globe.Position SummaryWe are seeking a motivated and detail-oriented Program Manager to support the development, deployment, and maintenance of software solutions for cutting-edge medical devices. The ideal candidate will collaborate with cross-functional teams to ensure project goals are met while adhering to regulatory requirements and quality standards in the medical device industry. This role provides an opportunity to contribute to life-saving technologies in a dynamic and innovative environment.Responsibilities and Duties:

• Program Coordination and Management--- Assist Sr. Program Manager in planning, scheduling, and tracking product development projects from initiation to completion.--- Coordinate with software engineers, quality assurance teams, regulatory affairs, and other stakeholders.--- Maintain project timelines, milestones, and deliverables while ensuring alignment with overall product development goals.
• Documentation and Compliance--- Ensure all project documentation complies with medical device regulations such as FDA 21 CFR Part 820, ISO 13485, ISO14971 and IEC 62304.--- Manage software requirements, design, risk management, and validation documents.--- Track and document changes to requirements, specifications, and project scope.
• Stakeholder Communication--- Serve as a point of contact between engineering teams, product management, and external stakeholders.--- Prepare and present project updates, reports, and metrics to senior management.--- Facilitate team meetings and cross-functional collaboration.
• Risk and Issue Management--- Identify, analyze, and mitigate project risks related to software development.--- Track and manage issues to resolution, ensuring minimal disruption to timelines.
• Quality and Process Improvement--- Support the implementation of Agile or hybrid project management methodologies tailored to the medical device industry.--- Participate in post-project reviews to identify areas for improvement and implement best practices.
• Support Regulatory Submissions--- Collaborate with regulatory and quality teams to provide necessary documentation and support for FDA, CE, or other global submissions.Requirements:--- Bachelor's degree in computer science, Software Engineering, or a related field.--- 1-3 years of experience in software project coordination or management, preferably in the healthcare or regulated industries.--- Familiarity with regulated environments (e.g., ISO, IEC standards and FDA guidelines).Skills:--- Strong organizational and time-management skills.--- Working knowledge of software development lifecycles (SDLC) and tools (e.g., Jira, Confluence, Git).--- Knowledge of Agile/Scrum or Waterfall methodologies.--- Excellent communication and interpersonal skills.--- Experience working with Product Marketing on user inputs and SW usability.--- Knowledge on software cloud access and cybersecurity, or equivalent are a plus.Salary Range- $ 132,000 - $166,000 (Annual Base Salary)The successful candidate's starting base pay will be determined based on job-related skills, experience, qualifications, work location and market conditions. The expected base pay range for this role may be modified based on market conditions.Equal Employment OpportunityAt Recor Medical, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Respecting your privacy is an essential part of the Company's privacy program and we are committed to the proper handling of Personal Information collected or processed in connection with an Applicant's application for employment, a Contract Worker's work, or a Former Employee's employment at Recor. Refer to our Applicant, Contract Worker & Former Employee Privacy Policy for more detail information.
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Keywords: Otsuka Pharmaceutical Co., Ltd, Palo Alto , Program Manager, Executive , Palo Alto, California