Senior Manufacturing Engineer

Working understanding of inspection methods and procedures (Test Method Validation). Demonstrate strong problem-solving skills and have the ability to ask critical questions without being the subject matter expert.

Interact with Product Development / R&D to ensure that processes and designs are manufacturable.

Design manufacturing processes, procedures and production layouts for assemblies, equipment installation and material handling.

Strong fixture design and development skills including mechanical design, tolerance analysis and material selection.

Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost, and improve productivity.

Experience using Six Sigma Methodology (DMAIC) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.

Initiate and lead lean manufacturing process improvement projects for high efficiency and cost effectiveness.

Maintain process and manufacturing documents.

Experience in documenting technical work and results, writing lab reports, and analysis / presentation of data.

Participate in process improvement projects to improve product quality, reduce rework / scrap, decrease cost, and improve product performance.

Analyze and plan workflow, equipment placement and space requirements to improve manufacturing efficiency.

Assist in scaling up equipment and processes from prototypes to pilot to full scale manufacturing.

Demonstrate hands-on process understanding and provide guidance and training to operators.

Troubleshoot production line issues related to yield, quality, and throughput.

Develop, verify, and validate manufacturing operations from process development to successful commercialization.

Manage and perform design verification, equipment qualification and product and process validations.

• Preferred Experience :

Fixture and tooling design to assist with manufacturing needs and process improvements

Proficient with SolidWorks to support fixture / tooling design and fabrication

Experience with DFM (Design for Manufacturing), DFA (Assembly), DFSS (Six Sigma)

Experience with the Medical Device Industry and the industry requirements to bring products into commercialization.

• Qualifications :
• Education :
• Bachelors Degree or masters degree in Mechanical ,Biomedical, or Industrial Engineering.
• Required Experience :
• 5+ years of equivalent industry experience.

Good understanding of Current GMPs and ISO 13485 standards.

Manufacturing or sustaining experience.

• Knowledge, Skills, and Abilities :

Strong communication and organizational skills.

Continual improvement process experience.

Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment.

Job Type : Full-time

Pay : $120,000.00 - $140,000.00 per year

Benefits :
• 401(k)
• Dental insurance
• Health insurance
• Paid time off

Schedule :

• 8 hour shift
• Monday to Friday

Work Location : In person

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