Senior Process Engineer

Job Title: Sr Process Engineer – Medical Devices

Location: Jacksonville, FL (Fully Onsite)

Type: W2 Contract

Technical Skills:

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 the development of new processes at suppliers and/or within internal manufacturing, implementing automation, and developing new fixturing

Education Required: Bachelor’s degree in engineering or technical field

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

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.