Johnson & Johnson · 12 hours ago
Staff R&D Engineer (Process Development) - Shockwave Medical
New Brighton, Minnesota, United States of America
Full-time
Onsite
Senior Level, Lead/Staff
$109K/yr - $175K/yr
6+ years expJohnson & Johnson is hiring for a Staff R&D Engineer (Process Development) to join their team located in New Brighton, Minnesota. This role will leverage advanced technical expertise to design and optimize innovative products for treating cardiovascular diseases and will involve leading prototype creation, overseeing pilot manufacturing, and guiding product transition from development to full-scale production.
Hospital & Health Care
Responsibilities
Design and develop product(s) for manufacturing in compliance with the company’s Design Control requirements and applicable regulatory requirements
Prototype and develop proof of concept process designs and bench models to test these concepts in a simulated environment
Develop, validate, and maintain test methods
Develop new catheter manufacturing processes based on design intent and DFM principles
Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies for manufacturing processes
Performs testing, analyze results and provides recommendations for design selection
Analyzes, evaluates, sources, and coordinates the procurement of new materials to support prototyping pilot operation and design verification and validation activities
Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing
Participates in technical design reviews to ensure all design inputs and user needs are met
Supports product development teams in executing projects from concept to commercialization
Supports base business and/or continuous improvement projects
Support commercial products as subject matter expert on product design, including design changes and regulatory inquiries
Responsible for ensuring proper documentation consistent with company’s quality system
Responsible for knowing and planning activities consistent the company’s quality policy and quality objectives
Supports pilot manufacturing as well as commercial production
Identify and maintain relationships with suppliers to ensure the delivery of superior components and services
Enhance the intellectual property position of the company via invention disclosures and patent applications
Supports 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 with 8 years' experience in medical device process development engineering or a Master's Degree in Mechanical or Biomedical Engineering and 6 years' experience in medical device process development engineering
Experience in developing catheters and access delivery systems from concept to commercialization
Experience in catheter devices process development from prototype creation to full-scale production
Experience in leading cross-functional technical teams
Experience in representing R&D/Process Development on a cross-functional core team
Experience with balloon expandable and/or self-expanding implants is a plus
Strong understanding of engineering materials, component selection, and design for reliability and manufacturability
Experience with CAD software (i.e. Solidworks)
Experience with statistical analysis and design of experiments (DOE)
Experience with computational modeling (i.e. finite element analysis, computational fluid dynamics) is a plus
Effective communication skills, written and verbal, 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
Experience developing disposable medical devices
Employee may be required to lift objects up to 25lbs
Preferred
Agile Decision Making
Coaching
Critical Thinking
Emerging Technologies
Engineering
Problem Solving
Process Control
Process Engineering
Process Improvements
Product Costing
Product Improvements
Research and Development
SAP Product Lifecycle Management
Situational Awareness
Technical Research
Technical Writing
Technologically Savvy
Vendor Selection
Benefits
Pension
401(k)
Long-term incentive program
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Company
Johnson & Johnson
At Johnson & Johnson, we believe health is everything.
10001+ employees
H1B Sponsorship
Johnson & Johnson has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (48)
2024 (56)
2023 (58)
2022 (59)
2021 (44)
2020 (27)
Funding
Current Stage
Late StageLeadership Team
Alex Gorsky
Former Chairman and CEO, Johnson & Johnson
Joaquin Duato
Chairman of the Board and Chief Executive Officer
Recent News
2025-10-07
2025-10-07
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