Catheter Engineer

Senior Catheter Engineer

Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Catheter Engineer located in Santa Clara, CA.

At Johnson & Johnson Robotics and Digital Solutions, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics and Digital Solutions was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH®), Surgical Robotics (OTTAVA™), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.

Overview:

The Catheter Engineer will work with other members of the design team to design and develop innovative robotic instruments. This role is responsible for conceptual and detailed CAD design, drawings, related documentation, and design specifications. Work will be focused on deriving and formalizing innovative designs based on user needs and product requirements in collaboration with robotic controls, system integration, clinical, quality, testing, external vendors, and manufacturing.

Core Job Responsibilities:

• Lead the design of new or existing steerable catheters, endoscopes and/or its subassemblies, including catheter construction, mechanical components, fluidic pathways, and seals, while ensuring that all design requirements are met.
• Create and maintain detailed CAD models and technical drawings utilizing GD&T principles.
• Develop specifications, requirements, work instructions, and test methods.
• Write protocols, reports, and engineering studies.
• Perform verification and validation activities.
• Develop concepts, designs, and details for machines, tools and fixtures.
• Interface with outside suppliers, communicate design intent, prototype designs and perform feasibility assessments at a rapid pace.
• Lead technical design reviews and present design inputs, outputs, and data to cross functional team members.
• Use analytical practices to collect data and translate it into objective, informed engineering decisions.
• Work hands-on in a laboratory to both prototype and evaluate feasibility of prototypes.
• Perform failure analysis and collaborate with other team members (manufacturing, electrical, software, mechanical, robotic controls, system, clinical, quality) to solve complex, system level design challenges.
• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Other duties may be assigned.

Qualifications

Required Experience and Skills:

• Minimum B.S (Mechanical, Biomedical Engineering, or equivalent) with industry experience. M.S. (Mechanical, Biomedical Engineering, or equivalent) or higher education is a plus.
• 3+ years of experience in disposable medical device engineering or similar field with increasing responsibilities in end-to-end product development.
• Experience with catheter and/or endoscope development.
• Experience working with catheter manufacturing processes such as coiling, braiding, laser-cut hypotubes, extrusions, films, bending sections, and bonding methods.
• Experience with CAD software (Solidworks, Creo or similar).
• Collaborative teammate with strong communication skills, written and verbal.
• Self-motivated, adaptive, high energy, strong work ethic, and a can-do demeanor. Experience working in a progressive, high-growth, evolving environment.
• Proven ability to effectively prioritize and run simultaneous tasks in an accelerated environment, and to exhibit flexibility to adapt to changing priorities.
• Excellent problem-solving skills, with a demonstrated ability to lead distributed technical teams and gain alignment with management in a fast-paced, collaborative environment.
• Ability to travel up to 10% domestically and internationally.

Preferred Experience and Skills:

• A strong understanding of concept development, 3D modeling, creating 2D drawings, GD&T, tolerance stack analysis, manufacturing methods, and rapid prototyping.
• Able to write and communicate clearly, including generating and presenting well-written reports.
• Understanding of test method and equipment setup and validation.
• Prior experience with fixture design and tooling development.
• Medical Device experience highly preferred.
• Experience with statistical analysis and design of experiments (DOE).
• Experience working with ISO 13485 and 14971, GMP guidelines, FDA regulations, medical device design control, and manufacturing scale-up processes.
• Familiarity with ISO 10993 standards and test methods, along with sterilization methodologies.
• Experience bringing products from concept through development and/or commercialization.

The company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the company's discretion on an individual basis.

Employees and/or eligible dependents may be eligible to participate in the following company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.

Employees may be eligible to participate in the company's consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the company's long-term incentive program.

Employees are eligible for the following time off benefits:

• Vacation – up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $103,000.00 to $165,600.00.