Johnson & Johnson MedTech · 20 hours ago
Staff R&D Engineer (Process Development) - Shockwave Medical
New Brighton, MN
Full-time
Onsite
Senior Level, Lead/Staff
$109K/yr - $175K/yr
6+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, dedicated to developing advanced treatments for complex diseases. The Staff R&D Engineer (Process Development) will focus on designing and optimizing innovative products for treating cardiovascular diseases, leading early prototype creation, and overseeing pilot manufacturing and testing.
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
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)
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
Employee may be required to lift objects up to 25lbs
Preferred
Experience with balloon expandable and/or self-expanding implants is a plus
Experience with computational modeling (i.e. finite element analysis, computational fluid dynamics) is a plus
Benefits
Employees are 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.
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
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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