Project Manager - Medical Device Development

About the job

Are you a Project Manager with a passion for bringing innovative medical and drug delivery devices to life? At Gilero’s Carlsbad, CA office, we are looking for a Project Manager to coordinate all project activities within multi-disciplinary teams for the design and development of medical and drug delivery devices.

In this role, you’ll drive complex projects from concept to commercialization, ensuring they stay on track, on budget, and meet the highest quality standards. If you thrive in a fast-paced, collaborative environment and like combining project management, engineering, and client relations to make a real impact, this is the opportunity for you. Join us and be part of a company that values innovation, integrity, and excellence—while offering outstanding benefits and career growth potential.

Duties:

• Organize project activities, lead the project team, prioritize and delegate tasks to team members in adherence with timeline and budget requirements
• Lead medical and drug delivery development projects consisting of electronic as well as manufacturing transfer projects encompassing multiple engineering disciplines
• Ensure project scope is maintained and/or manage out-of-scope requests
• Forecast engineering resources for short/mid/long-term project needs
• Generate financial and project reports for internal and external communication
• Liaise with the client for routine project updates, build relationships with clients
• Own project communication and stakeholder management
• Support Business Development through project timeline and budget preparation for new opportunities as well as project extensions
• Facilitate internal and external project meetings
• Evaluate project risk and establish risk mitigation measures. Escalate issues as needed and implement correct and preventive actions
• Grasp technical details with an ability to assist the team in decision-making
• Manage ongoing project timelines and budgets
• Maintain documents relating to the overall project (project plan, user needs, etc.). Ensure deliverables are being met and the customer is satisfied
• Coordinate vendor activities (suppliers, third-party labs, manufacturers, etc)
• Ensure team members comply with established QMS guidelines/procedures/work instructions
• Mentor junior team members and engineering interns.

Requirements:

• BS in Engineering or 4 year technical degree
• CAPM or PMP Certification (preferred)
• Must be willing to work on-site 3 days per week. The position offers the ability for remote work 1-2 days a week after an orientation period and remote work is dependent on the needs of the project stages.
• 4 years’ experience in medical device development and/or transfer role
• 2 years’ experience in a project management role.
• Knowledge of medical device regulations (FDA/ISO) a plus
• Possess strong project management skills and can work alone or in teams
• Strong writing skills and/or data analysis
• Ability to communicate effectively with customers and vendors in a technical capacity
• Competent computer skills, including Excel and Word

Personal Attributes:

• Meets Gilero Core Values: Collaboration, Integrity, Innovation, Excellence
• Comfortable and productive in a fast-paced, entrepreneurial environment
• A self-starter seeking a career opportunity with potential for internal advancement, seeking responsibility for core activities, and providing high-quality service to internal and external clients
• Commitment to excellence and quality service to external and internal customer
• Commitment to established policies and procedures, while contributing to continuous improvements

Why work at Gilero?

Founded in 2002, Gilero, a Sanner Group company, is an international contract engineering firm that specializes in the design, development, and manufacturing of novel medical devices and drug delivery products. At Gilero we are proud of the culture we have built that directly reflects our values of excellence, integrity, innovation, and collaboration. Motivated by our purpose to benefit people and improve patient outcomes, our team continue to grow at a rapid pace. US locations include NC locations in Raleigh, Durham, Greensboro, and Pittsboro, as well as Chicago, IL, and Carlsbad, CA.

You will enjoy an annual bonus plan, Medical (3 BCBS plans to choose from), Guardian dental and vision, company provided short-term and long-term disability, 401(k) with a 5% match the first month you start with a zero-vesting period.