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Empowering people, creating technology.

Responsibilities:

  • 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:

  • 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.

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Medical LLC

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Confirmed 15 hours ago. Posted 30+ days ago.

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