Johnson & Johnson MedTech · 15 hours ago
Sr Product Development Engineer
Johnson & Johnson MedTech is committed to healthcare innovation and seeks a Sr Product Development Engineer to enhance treatments in the Cardiovascular domain. The role involves leading product development efforts, innovating medical technologies, and ensuring compliance with quality and regulatory standards.
Hospital & Health Care
Responsibilities
Build and innovate current medical, technical, and biomedical developments related to company products and heart recovery technologies
Lead product development improvement efforts per plan and with little to no direct supervision. Prepare, present and lead design reviews to attain agreement on project with peers and cross-functional review team
Develop and update design documentation including test protocols, reports, and engineering rationales to support both quality and regulatory documentation
Develop Test Methods and understand requirements for Validation
Support and/or drive sustaining activities of existing product lines, including involvement with Corrective and Preventive Actions
Fabricate prototypes with assistance from junior staff, technical support team (Machine Shop, Technicians and Designers) and suppliers. Maintain accurate documentation of concepts, designs, and processes
Resolve producibility issues with internal and external manufacturing partners. Work with internal and external manufacturing partners to ensure producible designs (DFM). Document designs by constructing solid models and drawings using GD&T and stack-up analyses
Perform evaluations, design and prototyping using CAD (Solidworks), FEA, 3-D printing to accelerate development and engineering of plastics, ceramic, composite and metallic parts, electromechanical systems, etc
Qualification
Required
BS in Mechanical Engineering or directly related scientific field, MS Preferred
6 years of experience with Bachelor's degree, or at least 5 years of experience with a Master's degree
Thorough understanding of Medical Device Design Controls and Product Life cycle
Knowledge of FDA and EU MDR regulations
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) with stakeholders, project team, local and international
Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
Ability to act independently to resolve methods and procedures
Must be proficient in Microsoft Office Suite
Preferred
Product development experience in Class 3 Medical Device engineering
MSc/MEng Preferred
Applied understanding of DFM concepts and manufacturing best practices
Working knowledge of SAP and Minitab desired
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401k)
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.