Senior Product Development Engineer

Company : Freudenberg Medical

Location : Jeffersonville, IN - Onsite

Salary : $95,000

Responsibilities

• Translate user needs and other customer input into clear, concise design requirements and design concepts.
• 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.
• Create specifications for device components, assemblies, packaging, and labeling.
• Conduct &/or participate in brainstorming sessions to identify creative ideas and unique solutions.
• Contribute to the technical aspects of project including product design, verification, and validation.
• Work with Manufacturing and other Product Development engineers to ensure that products are optimally designed for manufacturing.
• The identification and selection of outside suppliers and consultants as required.
• 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.
• Lead the development of test and inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
• Prepare for and facilitate risk assessments throughout the product development lifecycle.
• 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 small quantities of prototype devices.
• Work with clients and client patent counsel to prepare invention records and assist in the patent submission process.
• Provide technical support to manufacturing engineering for design and process improvements made post transfer to sustaining manufacturing.
• In a non-supervisory capacity, 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.

Qualifications

• Bachelor of Science engineering degree, BSME or BSBME (or related discipline) and experience, in the medical device field.
• 7 + years’ experience in product development for a manufacturing company in medical device industry
• 5 years’ experience with catheters and catheter-based systems
• Knowledge of catheter molding design and assembly processes (extrusion, braiding, coiling, reflow, etc.)
• Technical product development experience, e.g. design, process, or quality engineering
• Working knowledge of both FDA and CE design controls
• Extensive experience with Solidworks is required
• 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/Skills

• Mechanical Design Degree
• Previous experience with interventional medical products: catheter based technologies (cardiovascular, neurovascular, peripheral vascular, etc.)

Job Type: Full-time

Pay: $85,000.00 - $95,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Tuition reimbursement
• Vision insurance

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Ability to commute/relocate:

• Jeffersonville, IN: Reliably commute or planning to relocate before starting work (Required)

Education:

• Bachelor's (Required)

Experience:

• Product Development: 7 years (Required)
• Manufacturing Engineering: 7 years (Required)
• catheters and catheter-based systems: 5 years (Required)
• medical device manufacturing: 7 years (Required)

Work Location: In person

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