Manager, NPI Engineering - Circulatory Restoration

Johnson & Johnson Innovative Medicine • Santa Clara, CA

3d • $121,000 - $209,300 • Onsite

About The Position

Johnson & Johnson is hiring a Manager, NPI Engineering – Circulatory Restoration in Santa Clara, California. The role provides leadership, technical support, and management and development of direct reports, and is responsible for product and process development, resources, and project management activities that support the company’s goals and objectives.

The manager leads cross-functional product development from concept through clinical trial and commercial release, with development and engineering activities focused mainly on catheter design and development. The position also provides technical leadership for process and technology development teams, coordinates internal and external resources, and ensures products and processes meet design-control, quality, regulatory, manufacturing, and customer requirements. The manager supports company policies, quality systems, and compliance with FDA and other regulatory bodies, and maintains knowledge of relevant competitive technologies and biomedical developments.

Requirements

• Bachelor of Science in Engineering or equivalent work experience.
• At least 10 years of progressive experience in medical device development, including at least 3 years 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 is preferred.
• Strong understanding of engineering materials, component selection, and design for safety, reliability, and manufacturability.
• Strong communication and presentation skills, including 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: 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, and mentor engineers and/or technicians.
• Lead cross-functional project activities from concept through clinical trial and commercial product release.
• Mentor and support development and engineering activities, primarily involving 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 activities in developing new and improved products and manufacturing processes.
• Ensure development activities are documented in lab notebooks, history files, Engineering Reports, and other records.
• Coordinate cross-functional alignment and support for program success.
• Manage outside vendors and contractors providing products or services.
• Create, maintain, and communicate timelines for internal and external development projects.
• Provide project teams and management with regular updates on milestones and issues.
• 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 all stages of product development.
• Review and approve documents as specified in Document Control SOP.
• Compile the Design History File and conduct design reviews in compliance with design-control procedures.
• Ensure products have capable manufacturing processes and that process verifications and validations are completed.
• Coordinate with cross-functional groups to ensure products and processes are compatible with the intended operating system and meet design-control requirements.
• Provide technical leadership for projects, including management of process and technology development teams.
• Maintain current knowledge of competitive technologies and biomedical developments relevant to company products.
• Ensure products and processes meet acceptable quality standards and customer needs in coordination with cross-functional groups.
• Support company goals, policies, procedures, quality systems, and compliance with FDA and other regulatory bodies.
• Perform other duties as assigned.

Benefits

• Annual performance-based cash bonus, subject to the applicable plan and company discretion.
• Medical, dental, and vision programs.
• Life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Company consolidated retirement plan (pension) and savings plan (401(k)), subject to eligibility.
• Vacation of up to 120 hours per calendar year.
• Sick time of up to 40 hours per calendar year; up to 56 hours for employees residing in Washington State.
• Holiday pay, including floating holidays, of up to 13 days per calendar year.
• Work, Personal and Family Time of up to 40 hours per calendar year.

What This Job Offers

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