Johnson & Johnson MedTech · 14 hours ago
Senior Component Engineer
San Jose, CA
Full-time
Onsite
Mid, Senior Level
$109K/yr - $175K/yr
5+ years expJohnson & Johnson is a leader in healthcare innovation, dedicated to developing smarter and less invasive treatments. The Senior Component Engineer will lead technical efforts in managing electronic and mechanical components, collaborating with suppliers, and ensuring compliance with quality standards.
Hospital & Health Care
Responsibilities
Lead technical efforts in selecting, qualifying, and managing electronic or mechanical components for products
Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies (PCBAs, consoles, cables, batteries, housings, etc.) as well as custom injection molded or extrusion components and/or multi-component sub-assemblies
Support product development projects as a liaison responsible for supplier interactions and work you're doing
Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be implemented at supplier
Partner with internal design teams to assess product lifecycle design changes and develop and implement qualification test plans
This role requires a blend of deep technical expertise and interpersonal skills to collaborate with various teams, resolve sophisticated issues, and drive component-related strategies for the entire organization
Lead frequently recurring meetings with suppliers to manage engineering projects, including process validations, failure analysis, component obsolescence mitigations and manufacturing capacity increases
Ensure components meet technical specifications, quality standards, and regulatory
Collaborate with external suppliers and internal partners to develop molded components
Identify and evaluate injection molding suppliers
Plan, develop, qualify, and stabilize component development process solutions for NPD projects
Provide guidance on second source selection and qualify processes at second source suppliers
Review supplier mold tooling designs and qualification plans, write Qualification Protocols and Reports
Handle an approved parts list, addressing component obsolescence, and ensuring compliance with industry standards
Review supplier test and validation reports
Follow up on component related issues, FA and requalification
Provide technical support to advanced sourcing and R&D
Work with advanced sourcing in handling lifecycle issues and sourcing strategies
Works multi-functionally with other engineering managers, marketing, sales, and engineering personnel during the product development or revision to ensure project and/or job effectiveness
Identify, lead, and provide priorities and direction to external suppliers to satisfy manufacturing and development requirements for tooling, manufacturing, and inspections of direct material components
Responsible for ensuring robust requirements cascade from Design to Suppliers
Mentor staff on plastics component development
Qualification
Required
Bachelor's Degree in Mechanical or Electrical Engineering or related technical degree required
A minimum of 5 years of manufacturing process development experience, with a focus on plastics injection mold tooling and components development through process qualification required
Possess hands-on knowledge of mold tooling design, fabrication and assembly techniques
Demonstrated experience designing, improving or supporting manufacturing of injection molded and/or extruded plastics components
Familiar with various grades of polymers and additives inclusive of injection molding process development
Excellent verbal and written communication and social skills
Experience in the Medical Device industry or medical field or other regulated environment
Demonstrated knowledge of manufacturing principles, practices, and procedures
Strong Understanding of Validation Procedures & Statistical Analysis
Project Management experience
Demonstrated problem solving skills
Technical proficiency in statistical tools like Minitab
Application of GD&T
Business/financial competence
Able to work in a team based, collaborative environment
Preferred
Strong knowledge of process validations
Experience with supplier selection and qualifications
Technical proficiency in CAD tools like SolidWorks and/or AutoCAD
Six sigma and process excellence tools/methodologies
Strong knowledge in DFM
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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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