Senior Component Engineer

Johnson & Johnson•San Jose, CA

12d•$109,000 - $174,800•Onsite

About The Position

Johnson & Johnson is currently recruiting for a Senior Component Engineer to join our MedTech team in San Jose, CA. About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Purpose: 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.

Requirements

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

Nice To Haves

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

Responsibilities

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.

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)).
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