Design Quality Engineer I (m/f/d)

ZipRecruiter; Hechingen; Hybrid; EUR 45.000 - 75.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Design Quality Engineer to contribute to the development of life-saving medical devices. In this dynamic role, you will collaborate with R&D and cross-functional teams to ensure successful product launches while adhering to regulatory standards. Your expertise in design controls, process validation, and risk management will be pivotal in maintaining high-quality manufacturing practices. Join a forward-thinking company that values innovation and offers a supportive environment for professional growth. If you're a goal-oriented team player eager to embrace new challenges, this opportunity is perfect for you.

Leistungen

Hybrid Working

Business Bike

Company Pension

Subsidy for Canteen

Intensive Training with Mentoring Program

Qualifikationen

• Several years of hands-on experience in FDA/MDR regulatory industry.
• Specific experience in medical device design controls and validations.

Aufgaben

• Partner with R&D to support product development and launch.
• Execute design verification/validation protocols.

Kenntnisse

Design Controls

Process Validation

Risk Management

Statistical Analysis

Adaptability

Ausbildung

Bachelor's Degree in Engineering or Science

Tools

Quality System Regulations

ISO Standards

Jobbeschreibung

Job Description

It's a good feeling to know you're doing your best with purpose every day. At Artivion, we manufacture high-quality products and solutions for the treatment of aortic diseases. Together with surgeons worldwide, we save lives. In doing so, we rely on the strengths of each and every employee. Your strength counts, too: As an important link in the chain, you make a contribution to saving lives together with us. Contribute your strengths and let us grow together.

We are hiring a

Design Quality Engineer I m/f/d

Responsibilities:

• Partner with R&D and other cross-functional groups to support successful development and commercial launch of new products.
• Support the proper application of design controls, process validation, risk management, and the investigation/correction of design failures/challenges.
• Support the execution of design verification/validation protocols to demonstrate the design output fulfills the design input requirements.
• Provide hands-on support to validate test methods.

Minimum Requirements:

• Minimum of a Bachelor's Degree in an engineering or science field, or equivalent work experience.
• Several years of hands-on experience; preferably in an FDA/MDR regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current good manufacturing practices, quality system regulations, and ISO standards.
• Specific experience in medical device design controls for developing and preparing design specifications and effectively demonstrating that the design output fulfills the design input.
• Specific experience designing, preparing, executing, and statistically analyzing validations as well as developing report packages to approve equipment, processes, methods, and software.
• Goal-oriented team player with an open mind and a high level of adaptability, eager to embrace new ideas quickly.
• Ability to work independently with minimal supervision.

What We Offer:

• An exciting field of activity.
• An autonomous area of responsibility.
• Active participation in an inter-quality team.
• Intensive training with a mentoring program.
• Diverse benefits such as hybrid working, business bike, company pension, and subsidy for our canteen.

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