Product Development Engineer I

Freudenberg Group•Carpinteria, CA

About The Position

Working at Freudenberg: We will wow your world! Responsibilities: Execute project tasks and/or lead low complexity projects under close supervision. Create/maintain Design Controls documentation in accordance with established regulatory requirements and SOPs. Translate User Needs into Design Input Requirements to comply with regulatory requirements and best-practice standards. Perform testing to verify the design input requirements. Generate CAD models & drawings based on theoretical concepts. Build and test prototype devices. Identify suppliers in the context of product development activities. Coordinate testing with internal or external partners, including Design Validation to ensure devices meet user needs. Facilitate project team meetings. Select materials for prototypes and finished medical devices. Lead or assist in creating technical document, such as protocols and reports. Qualifications: 0-2 years of Medical Device design & development experience. Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline. Master’s degree preferred. 21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366. 3D solid modelling (e.g. SolidWorks or related software). Hands-on experience with machining and 3D prototyping methods preferred. Knowledge of silicone and plastic molding preferred. Good communication & interpersonal skills. Good mechanical, analytical & problem-solving skills. Willingness to learn and develop new skills. 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 Welcome to Freudenberg Without Freudenberg, indoor air would not be as clean, cars would not drive and wounds would not heal as quickly. And these are just three examples from thousands of our applications. 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 51,000 employees a networked and diverse environment where everyone can thrive individually. Be surprised and experience your own wow moments.

Requirements

0-2 years of Medical Device design & development experience.
Bachelor of Science in Mechanical, Biomedical Engineering, or related discipline.
21CFR Part 820.30 Design Controls, ISO 13485, ISO 14971 ISO 10993 and IEC 62366.
3D solid modelling (e.g. SolidWorks or related software).
Good communication & interpersonal skills.
Good mechanical, analytical & problem-solving skills.
Willingness to learn and develop new skills.

Nice To Haves

Master’s degree preferred.
Hands-on experience with machining and 3D prototyping methods preferred.
Knowledge of silicone and plastic molding preferred.

Responsibilities

Execute project tasks and/or lead low complexity projects under close supervision.
Create/maintain Design Controls documentation in accordance with established regulatory requirements and SOPs.
Translate User Needs into Design Input Requirements to comply with regulatory requirements and best-practice standards.
Perform testing to verify the design input requirements.
Generate CAD models & drawings based on theoretical concepts.
Build and test prototype devices.
Identify suppliers in the context of product development activities.
Coordinate testing with internal or external partners, including Design Validation to ensure devices meet user needs.
Facilitate project team meetings.
Select materials for prototypes and finished medical devices.
Lead or assist in creating technical document, such as protocols and reports.