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Jr. Project Engineer

inSync Staffing

Jr. Project Engineer

San Jose, CA
Full Time
Paid
  • Responsibilities

    Job Description

    POSITION QUALIFICATIONS:

    1. MINIMUM EDUCATION:
    • 4 year technical/ science degree or 4-year direct manufacturing/R&D experience
    • Understanding of manufacturing concepts
    • Good computer skills
    • Working knowledge of Microsoft Office applications including Word, Visio, and Project
    • CAD experience a plus
    1. MINIMUM EXPERIENCE:
    • 2-4 years of manufacturing experience in a medical device or other regulated industry
    • Knowledge of GMP and/or ISO Quality System requirements a plus
    • Highly developed written and oral communication skills and be able to work in a team environment
    • Must have good problem-solving skills and be able to work independently, organized.
    • Medical / Pharmaceutical experience a plus

    POSITION DESCRIPTION & RESPONSIBILITIES: PRIMARY JOB RESPONSIBILITIES: Apply engineering knowledge and managerial skills to the design, develop and manufacture new products as well as product changes and enhancements which are consistent with customer requirements and SSM Quality Objectives. Provide in-house leadership in procedural development projects, R&D/OPS logs, verification and validation process, resource management and design history files. Estimate staffing requirements and skills needed to create budget(s) and complete projects on- time and within budget. Supervise and coordinate activities of assigned engineers, technicians, associates and contractors. Responsible for reliability, and manufacturability of products or technologies developed. Establish strategic goals for projects and company. Direct project activities. Proficient in Process Development, Qualification and Validation activities Responsible for compliance with QSR and company procedures. SUPPORT OF: o Internal audits o Supplier audits o Material Review Board o Complaints investigation Analyzes returned products for failure modes and works with Quality Engineering to improve product quality and prevent future failures o CAPA and Client documentation and investigation Provide leadership, goal-setting, communications, and facilitation skills as needed to guide and motivate project personnel. Assure appropriate training and skill development is furnished to project staff as needed.

    • Provide input to company strategic and long-range business plan and ensure that development projects further those goals.
    • Negotiate with other development staff and company departments to resolve conflicts and bottlenecks affecting projects.
    • Responsible for directly interacting with customers and communicating project status, organize business reviews, project plans and budget.
    • Generate proposals/quotes and secure sales for ongoing and new customers. Active in sales presentations and other related activities. Be a frontline customer service representative.
    • Develop inspection and sampling plans with Quality Engineering
    • Develop quality metrics for manufacturing and manufacturing processes
    • Project team member representing Manufacturing Engineering, R&D and Operations (provided
    • PM does not have Quality Assurance authority).
    • Interface with customers representing company
    • Support manufacturing activities representing Manufacturing Engineering/R&D
    • Perform or participate in risk management analysis
    • Performs other duties as required

    SECONDARY JOB RESPONSIBILITIES: PROVIDE ENGINEERING SUPPORT o Development and documentation of manufacturing processes o Design and development of assembly tooling and equipment

    • Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, and FDA regulations.
    • Performs data collection and analysis to monitor trends in testing and manufacturing process results
    • Assist with Employee Quality System Training Programs
    • Create and foster a safe and inclusive work environment

    Company Description

    inSync Staffing is a staffing agency supporting over 90 Fortune 500 clients for their national contract needs. Our clients move very quickly in their contract hiring decisions. inSync Staffing is also 100% USA based, you will always be communicating to someone here in the USA!