To provide technical skills and expertise in automated equipment design and selection, manufacturing processes improvement and support, and product development support of product produced by Merz Aesthetics, Inc. Provide technical skills and abilities to assure process projects are meet schedule and budget commitments. Success is measured through the generation and implementation of projects that meet desired outcome, budget, timeline, and manufacturing goals.
Essential Duties and Responsibilities:
1. Implementation of new, improved and/or expanded manufacturing equipment/tooling/fixturing/processes for new and continuing products. Includes responsibility for project budgeting, design & interfacing with vendors of equipment and tooling, and maintaining appropriate documentation for new equipment and processes including qualification, verification, and validation.
2. Prioritize and coordinate with other engineering/Merz Aesthetics staff the efforts of the Manufacturing Engineering Technicians. Perform reviews of their work and task priorities as needed.
3. Troubleshoot equipment and processing issues in support of production goals. Determine calibration and maintenance needs of new equipment for manufacturing and R&D.
4. Estimate and establish new product costing; develop and implement necessary SOPís; establish processing, packaging, and test specifications for products and equipment.
5. Support R&D in the design, development, and implementation into manufacturing of new products, processes, and devices.
6. Maintain compliance to (and accelerate where possible) project time lines and plans; maintaining project or capital costs to within approved budgets.
7. Assist Regulatory personnel in the preparation of written responses to FDA for IDEs, PMAs and PMA supplements.
8. Write, review, and execute validation protocols and reports. Perform validations of new automation equipment, processes, water systems, and other process related equipment.
9. Provide an engineering-based validation review and input for CAPAs and deviations, review technical merits of proposed change control documentation.
Education and/or Experience (years):
∑ B. S. in Mechanical Engineering or other engineering discipline is required
∑ Minimum 5-7 years of medical device process experience is required, Class III medical device preferred
∑ Exposure and background with ISO 13485, medical device regulations, FDA, or other Quality system environment is required
∑ Good understanding of clean room environmental needs as related to equipment and processing
Knowledge, Skills and Abilities:
∑ Demonstrated project management skills
∑ Demonstrated creativity and problem-solving skills
∑ Strong mechanical (and/or electrical) aptitude and overall design abilities
∑ Strong communication and writing skills
∑ Computer skills and software proficiency with MS Office and familiarity with statistical software
∑ Ability to read, analyze, and interpret technical procedures and government regulations
∑ Working knowledge of SolidWorks 3D and/or AutoCAD software
∑ Familiar with PLC programming and schematic interpretation
State or Province