Sr. Technical Project Manager (on-Site, local only)

Gener8, LLC•Carlsbad, CA

2d•$123,008 - $205,013•Onsite

About The Position

We are seeking an experienced and dynamic Sr. Technical Project Manager to lead and coordinate projects within our consumables business line at our Carlsbad, CA facility, with occasional cross-site projects involving instrument hardware. The ideal candidate will possess strong leadership skills, technical knowledge of product development, and a proven track record in managing cross-functional teams. In this role you will be responsible for timely project delivery, profit & loss accountability, and customer satisfaction through the management of project related activities and resources. You must be an excellent leader and possess experience in managing staff of different disciplines to produce results in a timely manner. You must be able to develop efficient strategies and tactics to manage projects and handle client requests. Experience with FDA regulatory compliance and design quality is a plus, particularly for cross-site projects involving instrument hardware.

Requirements

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 experience in consumables and/or instrument product development.
Experience with consumables product development is required; instrument hardware development experience is a plus, particularly for cross-site projects.
Proven ability to manage cross-site, multi-disciplinary teams, ensuring project 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.
Must be a US Permanent Resident or a US Citizen for consideration.

Nice To Haves

PMP strongly preferred. Candidates with a PMP certification will be given priority.
Experience working in FDA-regulated environments and familiarity with ISO 13485 and/or 21 CFR 820 is preferred.
Working knowledge of project/program management software (e.g., Smartsheet, Power BI, MS Project) is a plus.

Responsibilities

Manage one or several concurrent contracts and budgets with annual revenues up to $2-5M ensuring financial accountability and profitability.
Oversee the execution of contracts, ensuring compliance with applicable regulatory standards (e.g., FDA, ISO 13485, where required) and client-specific requirements.
Participate, as needed, in the execution of documents and assessments such as 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 project deliverables meet or exceed expectations.
Ensure the highest standards of customer service and client satisfaction throughout all stages of the project lifecycle.
Collaborate with project managers and stakeholders at other sites on cross-site projects involving instrument hardware, ensuring alignment with project objectives.
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 project management processes, recommending and implementing best practices for operational efficiency.
Conduct thorough technical and project document reviews, ensuring compliance with applicable regulatory standards (e.g., FDA 21 CFR Part 820, ISO 13485, where required) 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 project metrics, identifying areas for improvement and optimizing performance.
Engage regularly with stakeholders to provide status updates, align project goals, and address any evolving requirements or challenges.