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gener8 · 13 hours ago

Program Manager (Life Sciences, Biotech, Regulatory)

San Jose HQ- Gener8, San Jose, CA, US

Full-time

Onsite

Senior Level

$123K/yr - $205K/yr

6+ years exp

Gener8 is a growing company that partners with the life science and medical industries. They are seeking an experienced Program Manager to lead strategic projects in healthcare, life sciences, and biotech instrument development while ensuring regulatory compliance and customer satisfaction.

ManufacturingSoftware

No H1B

U.S. Citizen Only

Responsibilities

Manage one or several concurrent contracts and budgets with annual revenues up to $15M ensuring financial accountability and profitability

Oversee the execution of contracts, ensuring compliance with FDA, ISO 13485, and client-specific requirements

Provide expertise on the execution of documents and assessments like dFMEA, pFMEA, Risk Management Plan, Hazard ID, Design Input Requirements, Design & Development Plan, and the DHF

Provide technical expertise to understand project-critical functions, specifications, and risks, delivering concise updates and solutions to clients

Collaborate closely with clients to understand their needs and preferences, ensuring program deliverables meet or exceed expectations

Ensure the highest standards of customer service and client satisfaction throughout all stages of the program lifecycle

Supervise and support project managers across multiple sites, ensuring alignment with program objectives and maintaining oversight of overall program health

Step in to own project management tasks when resource gaps occur, maintaining continuity of project execution

Create, maintain, and manage detailed project schedules, ensuring all tasks and milestones are tracked and completed on time

Continuously improve program management processes, recommending and implementing best practices for operational efficiency

Conduct thorough technical and project document reviews, ensuring compliance with regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485) and company protocols

Gather data for invoicing, budgeting, and project reporting to keep stakeholders informed on progress and financial status

Proactively identify and escalate issues, risks, or delays to senior management, providing recommendations for resolution

Collaborate with cross-functional teams (e.g., R&D, Engineering, Manufacturing) to develop comprehensive project budgets and accurate quotes

Track, evaluate, and report on program metrics, identifying areas for improvement and optimizing performance

Engage regularly with stakeholders to provide status updates, align program goals, and address any evolving requirements or challenges

Qualification

Hardware instrument developmentISO 13485FDA regulatory complianceProject management experiencePMP certificationLeadership skillsOrganizational skillsInterpersonal skillsProblem-solving skillsCommunication skills

Required

Must have hardware instrument development experience

Must have ISO 13485 and/or 21 CFR 820 experience

Working in FDA-regulated environments and a thorough understanding of ISO 13485 is required, and will be assessed during the interview process

Bachelor's degree in Engineering or a related field is required

6+ years of project management experience in healthcare, life sciences, or biotech industries, with a focus on instrumentation development and FDA regulatory compliance

Proven ability to manage cross-site, multi-disciplinary teams, ensuring project and program success

Strong leadership and organizational skills, with the ability to mentor and motivate teams

Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment

Exceptional interpersonal and communication skills (both oral and written), with experience in client-facing roles

Strong problem-solving and conflict resolution skills, with the ability to manage risk and navigate challenges effectively

Expertise in project/program management methodologies, tools, and techniques