Johnson & Johnson MedTech · 2 weeks ago
Principal R&D Engineer (Sustaining) - Shockwave
Santa Clara, CA
Full-time
Onsite
Senior Level, Lead/Staff
$141K/yr - $227K/yr
8+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on developing advanced treatments for complex diseases. The Principal R&D Engineer will lead projects in the development and sustaining of innovative medical devices, particularly in the area of arterial disease treatment, while collaborating with cross-functional teams and mentoring other engineers.
Hospital & Health Care
Responsibilities
Provide technical leadership for projects in coronary and peripheral artery space
Provide mentorship to other engineers and assignments to technicians as required
Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies for manufacturing processes
Supports pilot manufacturing as well as commercial production
Support commercial products as subject matter expert on product design, including design changes and regulatory inquiries
Prototype and develop proof of concept designs and test methods based on the defined user needs and requirements
Represent R&D in cross-functional teams that drive geographical expansion of products
Solve challenging and complex technical problems during the new product development process and in support of commercial products
Analyze, evaluate, source, and coordinate the procurement of new materials to support prototyping and pilot operation
Develop protocols/reports and perform product assessment as well as verification and validation testing
Perform process-related design tasks to support pilot manufacturing, utilizing Design for Manufacturing principles and working with assemblers to ensure robust processes
Identify suppliers and maintain relationships to ensure the delivery of superior components and services
Enhance the intellectual property position of the company via invention disclosures and patent applications
Participate as SME or core team member on product development team(s) that manage projects from concept through commercialization
Design and develop product(s) in compliance with the company’s Design Control requirements and consistent with applicable regulatory requirements
Ensure proper documentation consistent with company’s quality system
Responsible for knowing and planning activities consistent with the company’s quality policy and quality objectives
Maintain current knowledge of competitive technologies in addition to medical, technical, and biomedical developments related to company’s products
Support company goals and objectives, policies and procedures, Quality Systems, and FDA regulations
Other duties as assigned
Qualification
Required
Bachelor's Degree in Mechanical or Biomedical Engineering and 10 years' experience in engineering OR a Master's Degree and 8 years' experience in engineering
Experience in early-stage catheter and/or lead based cardiovascular device development
Knowledge of disposable structural heart device design, material selection, and testing is a strong plus
Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
Strong understanding of statistics including design of experiments, Gage R&R, capability, etc. is a strong plus
Strong teamwork skills and demonstrated ability to work closely with cross functional partners
Effective communication skills with all levels of management and organizations
Operate independently and adaptability to changing requirements
Ability to work in a fast-paced environment, managing multiple priorities
Employee may be required to lift objects up to 25 lbs
Preferred
Agile Decision Making
Coaching
Crisis Management
Critical Thinking
Disruptive Innovations
Emerging Technologies
Engineering
Organizing
Process Control
Process Engineering
Process Improvements
Product Costing
Program Management
Project Scheduling
Research and Development
SAP Product Lifecycle Management
Tactical Planning
Technical Research
Technical Writing
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
Long-term incentive program
Vacation – up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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