Sr Manufacturing Engineer - Exempt

This position is based in the vibrant city of Irvine, CA, known for its dynamic economy, excellent quality of life, and proximity to Southern California's beautiful beaches and attractions. Join a team that values innovation and excellence in a thriving community.

Must Have:

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

Nice to Have:

• Lean and Six Sigma knowledge

Responsibilities:

• Lead cost, safety, service (business continuity), and/or quality projects by managing project budgets, timelines, and resources to ensure successful implementation.
• Support cost, safety, service, and/or quality compliance projects.
• Lead the innovation, development, and/or optimization of existing manufacturing processes, including 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.
• Design sequences of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Provide technical and sustaining engineering support in manufacturing areas.
• Recommend and implement equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques, and production yields for existing products.
• Review product development requirements for compatibility with processing methods to determine costs and schedules.
• Interact 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 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. This position requires the candidate to be onsite, 5 days a week.

Product Line Support:

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

Additional Responsibilities:

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design the arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Design sequences of operations and specify procedures for the fabrication of tools and equipment and other functions that affect product performance.
• Adapt machine or equipment design to factory and production conditions.
• Incorporate inspection and test requirements into the production plan.
• Inspect the performance of machinery, equipment, and tools to verify their efficiency and investigate and initiate corrective action of problems and deficiencies to ensure product quality.
• Develop manufacturing processes that are applicable to statistical process control and may develop those techniques.
• Provide guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Ensure 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 an 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. Exchange 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 products.