Sr Manufacturing Engineer - Exempt

LanceSoft Inc; Irvine (CA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in the medical device industry is seeking a seasoned professional to lead manufacturing process optimization and project management initiatives. The role requires advanced knowledge and experience in equipment and process qualification, project management, and Lean Six Sigma methodologies. Candidates must possess a Bachelor's degree and have a proven track record of at least 4 years in relevant fields, contributing to innovative solutions and compliance with industry standards.

Qualifications

• Requires advanced knowledge of the job area through education and experience.
• Minimum 4 years of relevant experience required.
• May have practical knowledge of project management.

Responsibilities

• Leads cost, safety, service, and quality projects.
• Designs manufacturing processes and production layouts.
• Provides technical and sustaining engineering support.

Skills

Equipment and Process Qualification

Project Management

Lean Six Sigma

Education

Bachelor’s degree

Job description

Must Have:

• Equipment and Process Qualification
• Experience in the medical device industry
• Project Management

Nice to Have:

• Lean and Six Sigma knowledge

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 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 Required:

• Equipment and Process Validation
• Project Management (experience leading projects)
• Lean Six Sigma in a medical device production environment

Education Required:

Requires advanced knowledge of the 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 a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.

Years’ Experience Required:

4 years of relevant experience, or an advanced degree with a minimum of 2 years relevant experience.

Work Schedule:

Yes, 40 hours a week.

Location:

On site, 5 days/week.

Interview Timeline:

Preference: Week of June 9th - start interview process. Week of June 23rd - finish interview process. We can extend it for a couple of weeks if required considering we will have 3 openings.

Product Line Support:

Multiple NV product lines at Toledo Site since the resource will be leading and/or supporting process and cost optimization initiatives.

Responsibilities May Include:

• 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 the most efficient and productive layout.
• Adapts machine or equipment design to factory and production conditions.
• Incorporates inspection and test requirements into the production plan.
• Inspects performance of machinery, equipment, and tools to verify their efficiency, 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.

Specialist Career Stream:

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 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 the 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. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.

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

Required Knowledge and Experience:

Requires advanced knowledge of the 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 a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant experience.