Working at Freudenberg: We will wow your world!
Execute product development projects, including developing specifications, prototypes, and conducting design verification and validation activities in compliance with regulatory and quality requirements.
Translate customer requirements, user needs and/or other inputs into clear design requirements, specifications, and design input documentation (as applicable); participate in risk assessments, 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.
Prepare and maintain design control documentation (as applicable), including design input/output records, protocols, reports, and design history files in accordance with ISO, applicable regulatory and company standards.
Design, build, and validate devices, fixtures and methods, coordinate and execute testing with internal and external partners, analyse and document test results.
Select materials, identify and manage suppliers, and collaborate cross-functionally with NPI/ manufacturing, quality, regulatory, and suppliers to ensure designs are optimised for manufacturability, regulatory compliance, and cost -effectiveness.
Guide the development and optimization of manufacturing processes, including tooling design and process characterization in compliance with ISO standards, country-specific and GMP regulations.
Develop and maintain detailed manufacturing documentation, including BOMs, process flowcharts, work instructions, and test/inspection plans in compliance with quality system requirements.
Specify and coordinate the procurement, installation, and qualification (IQ/OQ/PQ) of manufacturing equipment, fixtures, and gauges to support efficient and reliable production.
Analyze and solve manufacturing issues using a structured, root-cause problem-solving approach and lead cross-functional teams to implement robust, permanent solutions.
Lead Lean/Six Sigma projects to improve productivity, quality, delivery, and cost; oversee Kaizen initiatives and eliminate waste in manufacturing processes.
Train and support technicians and operators through ongoing sustaining engineering activities.Support audits and compliance activities while maintaining a safe, organized, and compliant product development lab environment.
Provide informal mentorship and guidance to junior engineers or new team members, sharing technical knowledge and best practices.
Drive product launches by providing engineering input during transition to production, resolving technical issues, and contributing to continuous improvement efforts.
May train new team members and provide input to employee performance evaluations
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.
3+ years experience of engineering in medical device or related industry experience.
Solid understanding of medical device standards and regulations, particularly ISO 13485, ISO 14001, ISO 14971.
Proficiency in GMP principles and their application in medical device manufacturing, including country-specific regulatory requirements (i.e., 21 CFR 820 in the United States)
Working knowledge in 3D solid modeling and technical drawings.
Ability to generate complex prototypes using various materials and techniques to test and validate product designs.
Knowledge of biocompatibility requirements and material selection considerations
Execution of Design for Manufacturability (DFM) principles and process characterization activities to design and develop products that are manufacturable and cost effective.
Proficiency in manufacturing processes used in medical device production, such as running equipment, injection molding, extrusion, catheter manufacturing, and assembly, including the materials used.
Experience with Project Management and Project management tools (e.g. MS Project). .
Demonstrated experience with formal problem-solving methodologies, critical thinking, and deductive skills. Ability to work independently and also as part of a team in a fast-paced, results-oriented environment.
Ability to effectively communicate moderately 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, test reports, work instructions, standard operating procedures (SOPs), and production records.
Understanding of process validation principles and process window/repeatability studies, DOE’s, IQ/OQ/PQ, and how to validate manufacturing processes to ensure consistent product quality and necessary safety protocols.
Familiarity with product testing, test method validation and inspection methods to ensure compliance with specifications and standards.
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