Sr. R&D Engineering Project Specialist Shockwave Medical

Santa Clara County, CA - USA

Monthly Salary: $ 106000 - 170200

Posted on: 7 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara California United States of America

Job Description:

Johnson & Johnson is hiring for a Sr. R&D Engineering Project Specialist Shockwave Medical to join our team located in Santa Clara CA.

At Johnson & Johnson we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal. Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments. Ready to join a team thats pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview

The Sr. R&D Engineering Project Specialist will work with other R&D project team members to manage early-stage R&D project activities. Under minimal supervision the Sr. R&D Engineering Project Specialist will track design documentation status design changes procurement and management of materials collection and organization of test data configuration management of prototype and pilot units and other logistics as needed for early-stage R&D projects.

Essential Job Functions

Manage and track project document releases and changes within the Quality Management System.
Manage collection and disposition of project generated data.
Manage procurement receipt and handling of R&D project materials.
Release change orders associated with project documents equipment and materials.
Collaborate with Shockwave supply chain management operations and facilities for warehouse setup related to R&D materials.
Ensure compliance with Shockwave environmental safety and various regulatory requirements specific to R&D materials.
Manage assembly of prototypes pilot runs and controlled units for clinical study use.
Track configuration management of prototype and pilot builds.
Prepare systems and samples for testing.
Align timelines and shipment plans with project teams.
Other duties as assigned.

Requirements

Bachelors degree in biomedical electrical mechanical systems or relevant engineering discipline and a minimum of 5 years engineering experience in medical devices.
Experience with EN60601-1 and collateral standards as they apply to medical electrical equipment
Experience using issue tracking tools such as JIRA
Experience using source control repository tools such as GIT or SVN
Experience using requirements tracking tools such as JAMA
Strong organizational and time management skills
Excellent communication and interpersonal skills
Proficiency in logistics software such as Oracle Procurement
Able to operate in medical device regulated quality management system and manufacturing environment
Strong attention to detail analytical and problem-solving abilities
Ability to work well under pressure portray resilience
Knowledge of logistics and transportation regulations
Employee may be required to lift objects up to 25lbs

An internal pre-identified candidate for consideration has been identified. However all applications will be considered.

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 & 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 contact us via or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Analytical Reasoning Bioinformatics Biological Engineering Biological Sciences Biostatistics Coaching Data Savvy Detail-Oriented Feasibility Studies Inventory Management Preclinical Research Project Schedule Prototyping Research and Development Researching SAP Product Lifecycle Management Technologically Savvy

The anticipated base pay range for this position is :

$106000.00 - $170200.00

Additional Description for Pay Transparency:

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: - Experience:

Senior IC