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.
401K Match: Save for retirement with the company's help.
Diversity & Inclusion: We focus on providing an inclusive environment and recognize our diversity contributes to our success.
Sustainability & Social Commitment: We support social and sustainable projects and encourage employee involvement.
Performance Related Bonus: When you have an impact, you can reap the rewards.
Personal Development: We offer a variety of trainings to ensure you can develop in your career.
*Candidates must be legally authorized to work in the United States without current or future visa sponsorship*
We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off. Additional details will be shared during the recruitment process.
On-Site
Freudenberg Medical LLC
payments The expected salary range for this position is $120,000 to $150,000 annually, depending on skills, experience, and qualifications.
You support our team as
- Lead and manage multiple cross-functional product development projects, ensuring on-time completion of deliverables while providing technical leadership throughout the product lifecycle.
- Prepare and lead design/development documentation, such as design input/output records, protocols, reports, and design history files in accordance with ISO, applicable regulatory and company standards.
- Translate customer requirements, user needs and/or other inputs into clear design requirements, specifications, and design input documentation (as applicable); participate in and lead risk management activities, design/project reviews, and verification testing to ensure product safety and efficacy; apply engineering analysis, design principles, and risk management tools to drive sound design decisions.
- Develop and evaluate prototypes, generate drawings/specifications, select appropriate materials, develop processes, and collaborate with suppliers to support device design, process development and manufacturing in compliance with regulatory and quality requirements.
- Lead process characterization and design verification activities, including test method development, fixture design, execution of testing, and documentation of results.
- Partner with customers/clinicians, marketing, regulatory, quality, NPI/manufacturing, and external experts to develop novel medical devices, assess new technologies/processes, and ensure clinical relevance and manufacturability of designs.
- Provide engineering support for design/process changes and product launches, resolving technical challenges and driving continuous improvement initiatives.
- Support audits and compliance activities as a subject matter expert.
- Participate in intellectual property activities by contributing to invention disclosures, patent strategy discussions, and design differentiation.
- May be asked to provide input to performance review
- Formally trains and mentors' junior staff, or acts as a resource for colleagues with less experience
- Support business development activities and opportunities.
- Strong interpersonal and communication skills dealing with internal and external customers.
- Bachelor's/University degree in Engineering (Mechanical, Biomedical, etc.), or related science/technical field.
- 8+ years' experience of engineering in medical device or related industry experience.
- Extensive knowledge and understanding medical device standards and regulations
- Extensive knowledge of GMP principles and their application in medical device manufacturing, including country -specific regulatory requirements
- Knowledge of global regulatory requirements including risk management efforts and thorough risk assessments and mitigation strategies.
- Experience supporting customer/clinical studies, collecting data, and collaborating with customer/clinicians to ensure compliance with study protocols.
- Strong familiarity with rapid prototyping techniques.
- Experience with 3D solid modeling and technical drawings of medical devices desirable.
- Execution of Design for Manufacturability (DFM) principles and process characterization activities to design and develop products that are manufacturable and cost effective.
- Strong experience with Project Management (including organizing and facilitating meetings, project planning, balancing multiple projects, and budgeting) and Project management tools (e.g. MS Project).
- Knowledge of biocompatibility requirements and expertise in selecting appropriate materials for medical device applications and incorporating human factors engineering principles to optimize medical device usability and user experience.
- Knowledge of IP laws and practices, including patent applications and protection of proprietary technologies.
- Proven ability to lead cross-functional teams to achieve project objectives.
- Leadership skills in establishing and managing comprehensive design control processes, ensuring adherence throughout the product lifecycle.
- Ability to work independently and also lead small teams in a fast-paced, results-oriented environment.
- Ability to generate complex prototypes using various materials and techniques to test and validate product designs.
- Ability to effectively communicate complex technical issues and solutions to non-technical internal and/or external customers in both oral and written methods.
- Ability to create and maintain technical documentation, such as design specifications and test reports.
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
