Sr. Product Development Engineer

Freudenberg•Carpinteria, CA

11h

About The Position

Working at Freudenberg: We will wow your world! Responsibilities: 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.

Requirements

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.
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.

Nice To Haves

Experience with 3D solid modeling and technical drawings of medical devices desirable.

Responsibilities

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.