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Freudenberg Medical · 4 days ago

Product Development Engineer I

Carpinteria, CA

Full-time

Onsite

New Grad, Entry Level

$70K/yr - $85K/yr

0+ years exp

Freudenberg Medical is a trusted Contract Manufacturing Organization (CDMO) partner, delivering high-quality solutions for medical device and pharmaceutical companies. The Product Development Engineer I will execute project tasks, create and maintain design controls documentation, and coordinate testing to ensure devices meet user needs.

ManufacturingMedical Device

No H1B

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

Qualification

Medical Device designDesign Controls3D solid modellingMechanical EngineeringBiomedical EngineeringAnalytical skillsWillingness to learnCommunication skillsProblem-solving skills

Required

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

Preferred

Master's degree preferred

Hands-on experience with machining and 3D prototyping methods preferred

Knowledge of silicone and plastic molding preferred

Benefits

401K Match: Save for retirement with the company's help.

Personal Development: We offer a variety of trainings to ensure you can develop in your career.

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.

Corporate Events: We celebrate success as a team, because only together can we achieve our goals.

We offer a comprehensive benefits package that includes medical, dental, and vision coverage, retirement savings with company match and paid time-off.