Sr. Product Development Engineer

Sr. Product Development Engineer page is loaded## Sr. Product Development Engineer locations:
Carpinteria, CAtime type:
Full time posted on:
Posted Todayjob requisition :
R
** 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.#

Qualifications:

* 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,…