Project Manager

Job Description

Job Title:

Project Manager

Reporting to:

VP, PMO

Location:

San Jose, CA

Job Site:

On-Site

Job Description Revision Date:

January 2025

About us:

We know what it takes to be a key partner in life science and medical industries. Since 2002, Gener8 has guided our customers by turning their innovative concepts into reality by providing engineering design services and manufacturing complex instruments, software, and consumables. Our customers are striving for breakthroughs in research instruments and medical diagnostic and surgical devices that will help scientists and medical professionals understand patient conditions and provide better treatment. Gener8 is a growing company with offices in San Jose and Carlsbad, CA, Wilmington, MA, Indianapolis, IN and Cartago, Costa Rica.

Summary:

We are seeking an experienced and dynamic project manager with experience in NPI to lead and coordinate strategic programs and projects within our company, focusing on healthcare, life sciences, and biotech instrument development projects. The ideal candidate will possess strong leadership skills, technical knowledge of hardware instrument development and a proven track record in managing cross-functional teams and multi-site coordination.

In this role you will be responsible for timely project delivery, profit & loss accountability, and customer satisfaction through the management of program and project related activities and resources. You must be an excellent leader and possess experience in managing staff of different disciplines to produce results for hardware projects in a timely manner. You must be able to develop efficient strategies and tactics to manage projects and handle client requests. You must understand hardware development and hardware NPI design transfer, and lead FDA regulatory compliance and design quality to project teams.

Essential Duties and Responsibilities:

Manage one or several concurrent contracts and budgets with annual revenues up to $10M ensuring financial accountability and profitability.

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

Participate in the execution of documents and assessments like dFMEA, pFMEA, Risk Management Plan, Hazard ID, Design Input Requirements, Design & Development Plan, and the DHF.

Lead a cross functional team and a complex design through the NPI design transfer process from development to production.

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.

Supervisory Responsibility:

This position has no direct supervisory responsibility.

Qualification Requirements:

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.

5+ 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.

PMP strongly preferred. Candidates with a PMP certification will be given priority.

At Gener8, we envision a world where innovation moves at the speed of imagination, allowing technology pioneers to bridge the gap between idea and solution. A world where the innovations of today provide the foundation for future innovation, fostering new breakthroughs, bigger ideas, and a better future for humankind.

Message to applicants:

The salary range posted for this position reflects the projected hiring range for new hire, full-time salaries in U.S. locations, not including benefits. For non-sales roles the hiring ranges reflect base salary only. Hiring ranges for sales positions include base and incentive compensation target. Individual pay is determined by the candidate's hiring location and additional factors, including but not limited to skillset, experience, and relevant education, certifications, or training. Applicants may not be eligible for the full salary range based on their U.S. hiring location.

Company Benefits:

Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program.

Full-time