MDR - Sr Manufacturing Engineer - Exempt

Lancesoft; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Lancesoft in Milwaukee, WI seeks a Manufacturing Engineer to design and optimize production layouts, equipment installation, and processes for high-quality assemblies. You will ensure compliance with ISO 13485 and FDA Design Controls while applying Lean Six Sigma to improve efficiency.

As a senior individual contributor, you will guide design concepts, mentor colleagues, and collaborate with stakeholders to deliver validated, compliant manufacturing solutions in a dynamic environment.

Qualifications

• Requires a Baccalaureate degree and a minimum of 4 years of relevant experience OR a Master's degree with a minimum of 2 years of relevant experience OR a PhD with 0 years of relevant experience.
• Lean Six Sigma and problem-solving methods (DMAIC, FMEA, 5Whys)
• Experience in a regulated environment (ISO 13485, FDA Design Controls 21 CFR 820)

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Arrange machines within plant facilities for the most efficient and productive layouts.
• Set sequence of operations and specify tool and equipment fabrication procedures that affect product performance.
• Adapt machine or equipment design to factory and production conditions.
• Incorporate inspection and test requirements into the production plan.
• Inspect performance of machinery and investigate corrective actions to ensure quality.
• Develop processes applicable to statistical process control; may develop related techniques.
• Provide guidance to engineering regarding design concepts and specs to best use equipment and manufacturing techniques.
• Ensure processes and procedures comply with regulations.

Skills

IQ/OQ/PQ

Gauge R&R

DoE

Lean Six Sigma

Root Cause Analysis

FDA Design Controls

ISO 13485

Job description

Join our team in Milwaukee, WI, a vibrant city known for its rich history and dynamic growth, where you can leverage your expertise in manufacturing engineering to make a significant impact.

Key Skills

• Equipment Validation Experience (IQ/OQ/PQ, Gauge R&R, DoE, etc.)
• Lean Six Sigma and Root Cause Analysis (DMAIC, FMEA, 5Whys, etc.)
• Familiarity with working in a regulated environment (ISO 13485, FDA Design Controls 21 CFR 820)

Responsibilities

• Design manufacturing processes, procedures, and production layouts for assemblies, equipment installation, processing, machining, and material handling.
• Design arrangement of machines within plant facilities to ensure the most efficient and productive layout.
• Design sequence 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 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.

Technical Specialist Career Stream

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies.

Formulates, 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 R&D, systems, or initiatives related to new technologies or therapies -from design to implementation - while adhering to policies, using specialized knowledge and skills.

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. 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 job area. May manage projects, requiring delegation of work and review of others' work products.

Required Knowledge and Experience

Requires a Baccalaureate degree and a minimum of 4 years of relevant experience OR a Master's degree with a minimum of 2 years of relevant experience OR a PhD with 0 years of relevant experience.