12 month contract, potential for extension or conversion

Jacksonville, FL

Education Required: Bachelors degree in engineering or technical field

Years’ Experience Required: a degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Does this position require the candidate to be onsite or remote, if hybrid what does the onsite vs remote schedule look like? Onsite, 100% of the time

Responsibilities may include the following and other duties may be assigned:

• Provides technical and sustaining engineering support in a manufacturing area.
• Recommends and implements equipment and process modifications to meet quality standards and improve production efficiencies, manufacturing techniques as well as production yields for existing products.
• Integrates equipment and material capabilities to meet process module target specifications and technology target specifications.
• Reviews product development requirements for compatibility with processing methods to determine costs and schedules.
• Interacts with product design and development personnel to ensure that processes and designs are compatible.
• May develop and conduct statistical analysis or recommend additions to document work.
• Leads the innovation, development and/or optimization of new manufacturing concepts, processes and procedures for transfer to manufacturing operations. This can include scouting and feasibility work, material selection, process and equipment selection, tooling / fixture and equipment installation and assessment of inputs, outputs and alignment to requirements.
• Develops manufacturing processes that are applicable to statistical process control and may develop those techniques including the measurement systems.
• Ensures processes and procedures are in compliance with regulations.
• Lead process development, design transfer, and validation activities for neuromodulation devices within the local quality management system to meet the design requirements and manufacturability standards
• Participate in design and development activities, such as tolerance stack analysis, failure analysis, new risk (FMEAs etc.)
• Research and implement technology solutions and methodologies like Design, Reliability & Manufacturability (DRM)
• Lead initiatives to innovate and develop best-in-class process technologies at local manufacturing site
• Support process characterization and validation activities to ensure cost-effective manufacturing cycles, including IQ/OQ/PQ, control plans, MSA (inspection methods), AQL quantity, process flow, and manufacturing protocols
• Ensure suppliers deliver quality parts, materials, and services according to company standards
• Qualify suppliers through rigorous assessment and evaluation of procedures in compliance with enterprise processes
• Monitor supplier performance throughout the manufacturing cycle
• Evaluate and improve suppliers' internal functions and quality management systems through close partnership for shared quality standards
• Work collaboratively with suppliers to resolve quality issues and implement corrective actions
• Provide technical guidance and ensure quality compliance for Supplier Quality engagement throughout the New Product Development (NPD) lifecycle, including pre-market activities.
• Work with NPI teams to ensure seamless integration of new processes within respective quality management systems
• Facilitate communication between design engineering, advanced manufacturing engineering, quality, and supply chain teams to optimize project outcomes
• Support design and manufacturing teams to enhance device functionality and manufacturability
• Engage with regulatory and compliance teams to ensure adherence to industry standards and regulations
• Identify and carry out practical actions to solve technical problems using your new and existing skills in project management, six sigma tools, process characterization and technology development
• Collaborate, document, and present all learnings to project and functional teams

Must Have

• Ability to clearly document work, articulate and present ideas and tests results to a variety of audiences.
• Ability to work as a dynamic team player who can work effectively and proactively on cross-functional teams and on various R&D projects with strong attention to detail
• Experience in Design for Manufacturability assessment, including emphasis on reduction for complaint handling and released product monitoring
• Experience in Design transfer/Process Validation
• Experience working with contract manufacturers
• Knowledge of statistical methods and design of experiments (DoE)
• Medical device industry experience
• Self-driven engineer who can provide leadership to process development activities
• Strong knowledge and hands on experience in process characterization/development

Nice To Have

• Experience in developing products from concept phase to production release
• DRM certification
• Strong experience with development of new processes at suppliers and/or within internal manufacturing, implementing automation, and developing new fixturing