Principal Product Development Engineer-Catheters

Plans process flow, evaluates process capability, modifies tooling, builds tooling, and designs tooling. Plans, schedules, conducts or coordinates detailed phases of the engineering work in a part of a major project or in a total projects. Reviews test procedures and plans prior to implementation, as well as conduct failure analysis and inspection on products, processes and materials. Evaluates, selects, and applies standard engineering techniques and procedures while using judgment when making minor adaptations and modifications. Devises new approaches to problems encountered. Prepares all necessary paperwork and documentation for all projects undertaken.
Job Summary:

The primary purpose of this job is to makes decisions and recommendations that are recognized as authoritative and have a far-reaching impact on extensive engineering and related activities of the organization.

Accountabilities & Responsibilities:

Adheres to Integer's Values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.

Utilizes customer requirements to design innovative medical devices for vascular projects including Catheters. Assignments may begin as initial concepts based on user needs and evolve into "hands-on" prototyping to gain clinical design feedback.

Accountable for verification and validation testing to demonstrate product compliance.

The use of FMEA, tolerance analysis, design for manufacturability (DFM) and other methods to mitigate risk will be essential throughout the design process.

Provides planning inputs and executes on project deliverables to meet established metrics.

Utilizes design tools as required to optimize critical aspects of the design when required.

Develops and documents test methods to evaluate product performance.

Authors technical documents including but not limited to: technical memorandums, design verifications/validations, intellectual property applications, input/output matrices, and product specifications.

Prepares detailed engineering drawings or component specifications to define the product design.

Reviews product designs/drawings for compliance with applicable medical device standards, company requirements, customer contract requirements, and any other related standards.

Generates, reviews and approves engineering change orders.

Investigates root cause for product and process failures and establishes corrective actions.

Directs new product development programs.

Provides direction and administrative organization for the design and engineering services departments and sets priorities for utilization of resources on new programs.

Manages a global customer base and is responsible for interface/travel for customer interaction and communication. Works closely with customers and program management to establish, maintain and improve relationships.

Provides technical marketing strategy and direction to the company.

Develops new business and market opportunities.

May supervise and mentor lower level engineers, technicians, and operators.

Develops new and unique approaches to complex problems and advanced technology beyond previous company involvement.

Works in an office, lab and clean room environment.

Reviews, initiates, and approves engineering designs, reports, change orders, material and process specifications.

Investigates the use of alternate parts, materials or vendors to achieve improved performance and/or cost reduction. Maintains key technical interface with vendor base.

Performs other duties as required.

Education & Experience:

Minimum Education: Master's Degree orDoctorate preferred.

Minimum Experience: 10+ years of experience

Knowledge & Skills:

Special Skills: Proven leadership, communications and project management. Excellent interpersonal and collaborative team-building skills.

Specialized Knowledge: Technically renowned. SME in Catheter Development.