POSITION SUMMARY: Support engineering, compliance and Quality related projects. Sustains current products, materials, processes, or equipment (including capital equipment devices with software and hardware) with minimal supervision to maintain or improve current released device design and/or quality. Develop and executes plans for a design change projects, potentially including hardware and software verification and standard based safety testing. Compiles and analyzes operational, test, and research data to sustain technical specifications for current design or released products, processes, and materials. Qualified candidates must have the following job experience.

ESSENTIAL FUNCTIONS:

• Support project team on the following activities: product design and development, test of materials, development of specifications, process capability studies, research investigations, report preparation, and process/test documentation.
• Develop Test Methods and perform test method validation.
• Fabrication and evaluation of materials, components, devices, test fixtures and prototypes
• Generation, review and approval of necessary design history file documentations, such as Design and Development Plan, Design Input, Design Output, Design Verification, Design Validation, Design Reviews, Design Transfer, Design Changes, etc.
• Generation, review and approval of necessary Risk Management file and usability file documentations, such as Task Analysis, Fault tree Analysis, Hazard Analysis, use flow, DFMEA, UFMEA, PFMEA, etc.
• Identification of device improvement opportunities (quality, cost, performance)
• Lead effectively within a technical and project team environment, including conducting meetings and presentations, planning and tracking projects
• Working extensively with product managers, other engineers, technicians and cross-functional specialists, physicians, nurses, internal and external suppliers, and contract manufacturers as required
• Providing mentorship and work direction to junior-level engineers, engineering technicians and other cross-functional support personnel
• Assists with process flow documentation and design including process steps, workflow and material handling techniques.
• Develop new equipment designs with emphasis on concurrent engineering and improved productivity techniques.
• Assists with process documentation generation and maintenance.
• Participates in new equipment qualification and validation.
• Generate and execute protocols for engineering studies, design verification, design validation, Test methods, process validation (IQ, OQ, PQ), etc.
• Designs, and perform Design of Experiments to optimize processes.
• Statistically analyzes and documents test results in formal reports and laboratory notebook as necessary.
• Review Engineering Drawings for content and consistency, according to Client’s Standard Procedures.
• Generate documentation such as manufacturing and test procedures (MP, TP, QP, etc.).
• Perform Design of Experiments to optimize processes.
• Interface directly with assemblers, production supervisors, leads, engineers and management as required.
• Coordinate with the suppliers and external resources needed in developing and implementing new process/product plans.
• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on platform or derivative projects.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM’s, Routers, FMEA’s, etc.)
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Trains and/or provides work direction to technicians and engineers and may train manufacturing personnel when required as part of a validation.
• Review and approve change requests related to Product, Process, and Validation and Verification documentation.
• Develop quality documentation such as quality plans, standard operating procedures, and inspection procedures. Ensure regulatory, FDA, and ISO compliance in all areas of responsibilities.
• Identify industry best practices. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
• Ensure that required standards for products are documented in the product requirements (PR) specification and ensure compliance by performing quarterly gap analysis and reviewing applicable verification documentation
• Review and approve Process Qualifications, Test Method Validations, Gage R&R's, Process Capability studies, Design of Experiment (DOE), FMEAs (Design and Process), and production master control plans.
• Assist on open CAPAs/NCRs/Complaint evaluations.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
• Provide direction and lead the implementation of Acceptance Activities, First Article Inspections, In-Process Inspections, Sampling Plans, product/component testing, inspections, and acceptance criteria.
• Build Quality into all aspects of their work by maintaining compliance to all quality requirements
• Assists in special projects as needed.