Manager, NPI Engineering - Circulatory Restoration

Johnson & Johnson • Santa Clara, CA

1d • Onsite

About The Position

Johnson & Johnson is hiring a Manager, NPI Engineering – Circulatory Restoration to join its Cardiovascular team in Santa Clara, California. The role provides leadership, technical support, and management and development of direct reports. It is responsible for product and process development, resource management, and project activities supporting company goals and objectives.

The manager leads cross-functional development work from concept through clinical trial and commercial product release, with a focus on catheter design and development. The position coordinates engineering and technical personnel, vendors, and contractors; manages project timelines and communications; and ensures development documentation, design controls, quality standards, and regulatory requirements are met. The role also provides technical leadership for process and technology development and supports manufacturing capability, verification, and validation.

Requirements

• B.S. in Engineering or equivalent work experience.
• At least 10 years of progressive experience in medical device development.
• At least 3 years of experience leading projects through all phases of product development.
• At least 2 years managing direct reports or equivalent experience.
• Knowledge of QSR and applicable Quality System Standards.
• Experience developing disposable medical devices; coronary and/or vascular catheter experience preferred in the posting’s requirement statement.
• Strong understanding of engineering materials, component selection, and design for safety, reliability, and manufacturability.
• Strong communication and presentation skills, with comfort serving as a team spokesperson and leader.
• Experience taking a product from concept through clinical or commercial release.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Ability to work independently and as part of a team, with flexibility as requirements change.
• May be required to lift objects up to 25 pounds.

Nice To Haves

• Experience with disposable medical device development, preferably coronary and/or vascular catheters.
• Preferred skills listed: Agile Decision Making, Benchmarking, Crisis Management, Developing Others, Disruptive Innovations, Emerging Technologies, Inclusive Leadership, Leadership, Lean Supply Chain Management, Process Control, Process Engineering, Process Improvements, Product Costing, Program Management, Project Schedule, STEM Application, Team Management, Technical Research, and Technical Support.

Responsibilities

• Manage, lead, mentor, and develop engineers and/or technicians.
• Lead cross-functional project activities from concept through clinical trial and commercial release.
• Support product and process development, particularly catheter design and development.
• Design and develop products and processes in compliance with company Design Control requirements and applicable FDA, ISO, and MDD requirements.
• Coordinate technical personnel and their work on new and improved products and manufacturing processes.
• Ensure development activities are documented through lab notebooks, history files, engineering reports, and other records.
• Coordinate cross-functional alignment and support for program success.
• Manage external vendors and contractors providing products or services.
• Create, maintain, and communicate project timelines for internal and external development projects; provide milestone and issue updates to teams and management.
• Identify issues and recommend solutions for products in development.
• Contribute to new product development through product specifications, process development, and manufacturing technologies.
• Approve test methods, acceptance criteria, and test equipment for product development stages.
• Review and approve documents as specified in Document Control SOP; compile Design History Files and conduct design reviews in accordance with design control procedures.
• Ensure products have capable manufacturing processes and that process verification and validation are completed.
• Work with cross-functional groups to ensure product and process compatibility and compliance with design control requirements.
• Provide technical leadership for projects, including managing process and technology development teams.
• Maintain current knowledge of competitive technologies and biomedical developments relevant to company products.
• Ensure products and processes meet quality standards and customer needs, with cross-functional consensus.
• Support company goals, policies, procedures, quality systems, and compliance with FDA and other regulatory bodies.
• Perform other related duties as assigned.

Benefits

• Annual performance bonus eligibility, subject to the terms of the applicable plan and company discretion.
• Medical, dental, and vision coverage may be available to employees and/or eligible dependents.
• Life insurance, short- and long-term disability, business accident insurance, and group legal insurance may be available.
• Consolidated retirement plan (pension) and 401(k) savings plan participation may be available.
• Vacation: up to 120 hours per calendar year.
• Sick time: up to 40 hours per calendar year; up to 56 hours for employees residing in Washington State.
• Holiday pay, including floating holidays: up to 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager