Senior Product Development Engineer - Medical Devices

Location

Jeffersonville, IN | United States

Job description

Responsibilities arrow_right

• Leads functional teams or projects with substantial resource requirements, risk and complexity with importance for the organization.
• Work closely with Development team internal and external to ensure scope, expectations, and product requirements and design requirements are fully understood.
• Collaborate with Program Managers to meet and exceed external and internal customer expectations.
• Track and monitor budget and timeline, performance indicators and works closely with Operations team to ensure all facilities are prepared for new product launches.
• Utilize cross-functional participation to ensure that the equipment and process and processes are compatible with the entire value stream.
• Ensure design/process capability has been successfully completed before launch.
• Ensure the implementation of project schedules and define and implement equipment set needed to support Pilot & Full-Scale Production.
• Convert high level milestones to understood tasks that will be executed by the team.
• Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions.
• Create and document design concepts through the use of 3D CAD software and rapid prototyping methodologies
• Create concept models and prototypes utilizing small tools and equipment along with creating 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.
• 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.
• Support 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 while promoting employee development and foster growth of employees through effective mentoring.

Qualifications arrow_right

• Bachelor of Science engineering degree, BSME or BSBME (or related discipline) and experience, in the medical device field.
• 8 + years’ experience in product development for a manufacturing company in medical device industry
• Knowledge of catheter molding design and assembly processes (extrusion, braiding, coiling, reflow, etc.)
• Working knowledge of both FDA and CE design controls.
• 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.
• Preferred Qualifications
• Mechanical Design Degree
• Previous experience with interventional medical products: catheter-based technologies (cardiovascular, neurovascular, peripheral vascular, etc.)
• Project management training and or certifications.

Job tags

Salary