Sr. NPI Engineer

Working at Freudenberg: "We will wow your world!" This is our promise. As a global technology group, we not only make the world cleaner, healthier and more comfortable, but also offer our 52,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions from ideation and market launch to volume production for medical device and pharmaceutical companies. With proven expertise in materials and technologies, Freudenberg Medical offers an extensive range of vertically integrated capabilities: precision molding and extrusions, complex catheters, hypotubes, and coatings.

Some of your Benefits

#### 401K Match

401K Match: Save for retirement with the company's help.

#### Diversity \& Inclusion

Diversity \& Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.

#### Performance Related Bonus

Performance Related Bonus: When you have an impact, you can reap the rewards.

#### Safe Environment

Safe Environment: We strive to ensure safety remains a top priority, and provide a stable environment for our employees.

#### Relocation Allowance

Relocation Allowance: When you move close to our locations we offer financial aid to support you.

Candidates must be legally authorized to work in the United States without current or future visa sponsorship

Jeffersonville, IN

On-Site

Freudenberg Medical LLC

You support our team as

Sr. NPI Engineer

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Responsibilities

• Ownership of the process validation plan and associated process risk documentation.
• Solves complex problems and helps coach and mentor other Engineers.
• Establish Root cause and provide solutions quickly.
• Develop manufacturing processes. Utilize cross-functional participation to ensure that the equipment and process and processes are compatible with the entire value stream. Efforts should include: Early equipment management, workstation design, material presentation, standard work and single piece flow.
• Working with PD team, ensure design/process capability has been successfully completed before launch.
• Define and implement equipment set needed to support Pilot \& Full-Scale Production
• Develop test fixtures and prototype tooling as needed to support the manufacturing line development.
• Define and control production process including tooling and equipment. Validate design specifications and shop floor application of new product, tools, or equipment.
• Prototype equipment designs quickly with a combination of in-house machining and contract manufacturers
• Drives effort of identifying and implementing affordable error proofing and automation technologies.
• Ensure the implementation of project schedules
• Working closely with Operations team to ensure all facilities are prepared for new product launches
• Supports the development and use of all production and control related processes and documentation including APQP, Control Plans, Qualification Plans, Engineering Change, Deviations, Corrective and Preventative Actions, DFMEA, PFMEA, PPAP, FAI, DFMA, and SPC tools
• Identify and establish new processes and technologies necessary to achieve best cost targets
• Provide coaching, and guidance regarding project tasks to other engineers, designers, technicians and associates.

Qualifications

• Required Qualifications:
• Bachelor’s Degree required,
• 8\+ years of experience required.
• Detail oriented with excellent project management skills
• Track record of working in fast paced environments
• Ability to work on many different projects at the same time
• Strong interpersonal, oral and written communication skills with the ability to effectively communicate with all levels of the organization, customers and suppliers
• Preferred Qualifications:
• Green Belt certification in Lean or Six Sigma.
• Experience in designing, procuring, assembling, troubleshooting and validating equipment
• Working knowledge of SolidWorks and AutoCAD software, 2D\& 3D.
• Experience in a structured regulatory environment with advanced quality systems such as ISO13485, ISO 9001,
• Master’s Degree in Mechanical/Electrical/Bio-Medical Engineering preferred

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. #LI-MEDICAL