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Freudenberg Medical · 1 day ago

Sr. Product Development Engineer

Jeffersonville, IN

Full-time

Onsite

Senior Level, Lead/Staff

8+ years exp

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner dedicated to delivering high-quality solutions for medical device and pharmaceutical companies. The Sr. Product Development Engineer will be responsible for creating design concepts, developing prototypes, and ensuring designs meet functional requirements while collaborating with manufacturing teams.

ManufacturingMedical Device

No H1B

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

Qualification

Product Development3D CAD SoftwareInterventional Medical ProductsTechnical WritingProject ManagementStatistical AnalysisLeadershipOrganizational SkillsTeamworkCommunication Skills

Required

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