J&J Family of Companies Project Manager, Research & Development in Milpitas, California
Johnson & Johnson Surgical Vision (JJSV) is recruiting for a Project Manager, Research and Development to be located in Milpitas, CA. JJSV designs, manufactures, and distributes products for the surgical treatment of anterior segment ophthalmic disorders, most notably cataract removal.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
The Johnson & Johnson Surgical Vision goal is improving sight throughout a patient’s lifetime. J&J Surgical Vision is well positioned to address a full range of vision health needs for global markets: The No. 2 global provider of CATARACT products and a leader in presbyopia-correcting IOLs, the Global REFRACTIVE (LASIK) market leader, all supported with a CONSUMER EYE HEALTH diverse portfolio of solutions and drops.
Johnson & Johnson Surgical Vision has operations in the United States, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Our associates around the world are committed to expanding our brands and fortifying our position as the worldwide leader in the industry.
The Project Manager, Research and Development (R&D) will lead teams in the delivery of global new projects through the JJSV Product Delivery Process and will be accountable for guiding the cross-functional teams to ensure strategic alignment and execution of the project deliverables, on schedule, within budget, and to the required quality / reliability standards. The Project Manager, will apply best practices and tools to deliver new products consistent with the business’s strategy and objectives. This person is a technically strong individual who works directly with the Technical Leads, Functional Managers and Business Leaders to identify and coordinate the resolution of technical and project risks. The Project Manager provides timely and effective communication of project progress, advocates for resource and budgetary needs, and uses a leadership style that inspires teamwork, high standards, compliance and overall success in project results for the benefit of the customer and the company.
Responsible for and compliance with applicable Corporate and Divisional Policies and procedures
Develop and ensure all deliverables (project and technical) are well understood by the project core team
Lead project team to appropriately challenge project assumptions and thoroughly identify the project and technical risks
Work closely with Program Manager or Senior Project Manager and update status on daily basis Prepare project schedule, ensuring timing estimates from the cross-functional team are accurate and appropriately challenged, including buffers to mitigate risks
Organize and deliver presentations to management, including the Global New Product Process
at stage gate meetings
Execute high quality, integrated cross-functional project plans including development of project
charter, schedule, milestones, budget, risks, issues and resources needed
Be the primary point of contact for the project and interface with Technical Leader on technical
issues, Functional Manager on resource issues and Executive Sponsor on project issues
Facilitate cross-functional communication between R&D, Marketing, Operations, Quality Assurance and Clinical/ Regulatory organizations
Lead project team meetings, develops and manages agenda, minutes, and follow up action items
Lead engineering efforts for multiple medical products and keep track of DHF documentation
Plan, schedule and prepare DHF deliverables and track each activity till closure.
Prepare reports; maintain files and records
Responsible for project communication, managing product traceability, and product requirements; design reviews and risk management activities
Resolve issues, conflicts and project bottlenecks as they arise, negotiating effectively with others
Drive recovery effort so issues do not impact overall schedule
Ensure projects run in compliance with Design Control Regulations
Supervise the activities of other lower-level personnel
Adheres to environmental policy, procedures, and supports department environmental objectives
A minimum of a Bachelors degree in an Engineering or Science field is required
A minimum of 5 years of professional experience in a regulated industry is required
Experience in Medical Device is preferred
A minimum of 4 years of engineering and/or operational experience is required
A minimum of 3 years of experience in R&D new product development in a technology-driven manufacturing industry is required
A technical background in health care, laboratory diagnostics, medical devices, or pharmaceutical companies is preferred.
Experience managing technical core team members and groups of engineers, either by direct report or by influence is required
A solid understanding and management of procurement & contracting processes is preferred
Experience successfully delivering new products through entire development cycle, from concept through launch is required
Practical working knowledge of each of the following is required:
ISO 13485 / 14971
FDA / MDD / CE
IEC 62304 / 62366
Design Controls / Design History File
Validation & Verification
This position is located at our company site in Milpitas, CA (not remote options), and will require approximately 20% travel is required
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