Manufacturing Engineer

Grove Technical Resources; Irvine (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

Grove Technical Resources is seeking a seasoned Manufacturing Engineer to lead cost, safety, service and quality initiatives within medical device production. You will manage project budgets, timelines and resources, and drive optimization of manufacturing processes and layouts.

The ideal candidate has expertise in equipment and process validation, project management, and Lean Six Sigma in a medical device setting, plus a Bachelor's degree and 4+ years of relevant experience.

Qualifications

• Requires Bachelor's degree or higher with 4+ years of relevant experience.
• Advanced degree with 2+ years relevant experience preferred.
• Experience leading projects and managing budgets.

Responsibilities

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Manages arrangement of machines within plant facilities for efficient layout.
• Designs sequence of operations and specifies procedures for fabrication of tools and equipment and other functions affecting product performance.
• Adapts machine or equipment design to factory and production conditions.
• Inspects performance of machinery, equipment, and tools to verify efficiency and initiates corrective actions.
• Develops manufacturing processes applicable to statistical process control and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements.
• Ensures processes and procedures comply with regulations.
• Delivers and/or manages projects from design to implementation.

Skills

Equipment and Process Validation

Project Management

Lean Six Sigma in medical device env

Education

Bachelor’s degree

Advanced degree (optional)

Job description

• Leads cost, safety, service (business continuity) and/or quality projects by managing project budget, timeline and resources to ensure successful implementation
• Supports cost, safety, service and/or quality compliance projects
• Leads the innovation, development and/or optimization of existing manufacturing processes
• This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements to optimize manufacturing operations
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Provides technical and sustaining engineering support in a manufacturing areas.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Interacts with product design and development personnel to ensure that processes and designs are compatible.

Top 3 technical skills that are required for the role:

1. Equipment and Process Validation

2. Project Management (experience leading projects)

3. Lean Six Sigma in a medical device production environment

Education Required:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management. Requires a Bachelor’s degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Years’ Experience Required: 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Responsibilities may include the following and other duties may be assigned.

• Designs manufacturing processes, procedures and production layouts for assemblies, equipment installation, processing, machining and material handling.
• Designs arrangement of machines within plant facilities to ensure most efficient and productive layout.
• Designs sequence of operations and specifies procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapts machine or equipment design to factory and production conditions.
• May incorporate inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
• Develops manufacturing processes that are applicable to statistical process control, and may develop those techniques.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensures processes and procedures are in compliance with regulations.
• Typically, an individual contributor with responsibility in a professional discipline or specialty.
• Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• May act as a mentor to colleagues or may direct the work of other lower level professionals.
• The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

Differentiating Factors Autonomy:

• Seasoned individual contributor.
• Works independently under limited supervision to determine and develop approach to solutions.
• Coaches and reviews the work of lower level specialists; may manage projects / processes.

Organizational Impact:

• May be responsible for entire projects or processes within job area.
• Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

Innovation and Complexity:

• Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties.
• Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.

Communication and Influence:

Communicates with senior internal and external customers and vendors.

Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision making.

Leadership and Talent Management:

• May provide guidance, coaching and training to other employees within job area.
• May manage projects, requiring delegation of work and review of others' work product.

Required Knowledge and Experience:

• Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.
• May have practical knowledge of project management.
• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.