Sr. Product Development Engineer

Freudenberg NOK•Jeffersonville, IN

46d

About The Position

Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions. Create and document design concepts using 3D CAD software and rapid prototyping methodologies. Create concept models and prototypes utilizing small tools and equipment. Create specifications for device components, assemblies, packaging, and labeling. Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing. Assist in the identification and selection of outside suppliers and consultants as required. Determined to develop concepts and prototypes including design specifications and processes to properly make and assemble new medical products. Driven to assist as needed to complete project deliverables ranging from prototypes to manufacturing transfer tasks. Prepare for and conduct various design reviews in accordance with regulatory requirements. Verify that designs meet functional requirements through the performance of engineering analyses and testing. Assist in the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated. Utilize common laboratory test equipment to perform hands-on mechanical and electrical testing. Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports. Specify fixtures, gauges, and equipment needed for the verification and manufacture of devices. Provide technical support to manufacturing engineering for design and process improvements made post transfer to sustaining manufacturing. Provide coaching, and guidance regarding project tasks to other engineers, designers, technicians, and associates. Promote employee development and foster growth of employees through effective mentoring. Ensure design/process capability has been successfully completed before launch.

Requirements

Bachelor of Science engineering degree, BSME or related discipline and experience, in the medical device field.
8 + years' experience in product development for a manufacturing company.
Experience working in a regulated environment.
Strong technical writing ability.
Leadership ability and organizational skills.
Strong team oriented professional with good interpersonal skills who is hands-on with a high energy approach to work.
Proficiency in the use of PC and programs, particularly Project, Excel, Word, PowerPoint.
Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) both to senior management, customers and associates.
Execute tasks in a timely manner without direct supervision.
Ability to prioritize tasks.

Nice To Haves

Previous experience with interventional medical products:catheter-based technologies (cardiovascular, neurovascular, peripheral vascular, etc.)
Project management training and or certifications.

Responsibilities

Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions.
Create and document design concepts using 3D CAD software and rapid prototyping methodologies.
Create concept models and prototypes utilizing small tools and equipment.
Create specifications for device components, assemblies, packaging, and labeling.
Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing.
Assist in the identification and selection of outside suppliers and consultants as required.
Determined to develop concepts and prototypes including design specifications and processes to properly make and assemble new medical products.
Driven to assist as needed to complete project deliverables ranging from prototypes to manufacturing transfer tasks.
Prepare for and conduct various design reviews in accordance with regulatory requirements.
Verify that designs meet functional requirements through the performance of engineering analyses and testing.
Assist in the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
Utilize common laboratory test equipment to perform hands-on mechanical and electrical testing.
Analyze test data using statistical tools, perform in-depth interpretation of results, and generate detailed technical reports.
Specify fixtures, gauges, and equipment needed for the verification and manufacture of devices.
Provide technical support to manufacturing engineering for design and process improvements made post transfer to sustaining manufacturing.
Provide coaching, and guidance regarding project tasks to other engineers, designers, technicians, and associates.
Promote employee development and foster growth of employees through effective mentoring.
Ensure design/process capability has been successfully completed before launch.