Sr. Manufacturing Engineer

Posted 2 weeks ago
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Job Description
Position Title: Senior Manufacturing Engineer
Department: Manufacturing
FLSA Status: Exempt

Scope of Job

Job Summary: The Senior Manufacturing Engineer leads and performs efforts to identify, design, implement, and improve new and existing manufacturing processes. This position will report to the Executive Director of Engineering and R&D.

Essential Functions
To include, but are not limited to the following:

Manufacturing Excellence. Lead the design, implementation, and optimization of manufacturing processes and equipment. Continually analyze manufacturing process flows and equipment to identify potential enhancements in quality, cost reduction, and throughput.
External Partner Relations. Collaborate with Eyenovia’s Contract Manufactures (CMs) and Vendors to qualify for, design, and create highly reliable processes to produce consistent, high-quality product. Identify and mitigate potential supply and manufacturing risks to ensure continuity of supply. Partner with the Operations team to identify, analyze, and qualify new suppliers.

Internal Team Guidance. Work with various Eyenovia manufacturing teams to ensure manufacturing excellence. Participate in active builds to help identify opportunities for process improvements and increased throughput. Provide training to ensure manufactured product adheres to Eyenovia quality standards.

Resolution of Line-Down Issues. Treat line-down, or “red light” issues as top priority and adjust schedule accordingly. Resolve line-down issues in a timely manner. Collaborate with manufacturing teams and technical personnel to identify and correct contributing root causes to ensure issues are not repeated.

Manufacturing Scheduling. Work with key stakeholders throughout the company to help quantify manufacturing capacity at various Eyenovia and CM facilities. Conduct manufacturing line time studies. Assist in preparation and maintenance of demand/capacity schedules to help ensure manufacturing output is balanced with customer demand.

Compliance (Manufacturing Standards and Specifications). Responsible for creating, maintaining, and improving manufacturing related documentation (e.g., manufacturing instructions, lot history records, etc.). Routinely assess internal and external manufacturing team’s adherence to standards. In the event of non-adherence finding, provide corrective training as necessary.

Engineering Improvement and Troubleshooting. Apply knowledge of product design, assembly, tooling, automation, and materials to collaborate with engineering teams to implement design and process improvements. Plan and execute R&D bench testing or validation studies to assess viability of conceptual process improvements. Produce detailed test reports.

To include, but are not limited to the following:

• Minimum of Bachelor of Science (BS) in Engineering or similar discipline from an accredited college or university with 10 years of engineering experience, preferably in medical device, pharmaceutical, or other regulated industry.

• Advanced Degree preferred.

• Experience designing processes in a medical device manufacturing environment preferred.

• Broad understanding of medical device development processes compliant with 21 CFR 820 and/or ISO 13485.

• An availability to travel to vendors and contractors’ facilities. This includes domestic and international locations. Frequency could be as high as one full week per month.

• Expertise in Microsoft Office applications.

• Excellent written and verbal communication and interpersonal skills. Ability to work collaboratively across all functional groups and all levels.

• Highly motivated, goal orientated achiever with ability to prioritize and organize own work independently.

• Excellent problem-solving skills.

• Proficiency with written and spoken English.

• Excellent organization skills.

• Physical Requirements: standing, sitting, walking, stairs, light lifting, computer operation

Eyenovia is an equal opportunity employer. Eyenovia offers a competitive benefits package including medical, dental, PTO, and holidays

Job Features

Job CategoryManufacturing

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