Design Quality Engineer II, Medtec Experience required

Johnson and Johnson; Aachen; Vor Ort; EUR 50.000 - 70.000; Vollzeit

Zusammenfassung

A leading company in healthcare innovation is seeking a Quality Engineer to lead New Product Development and ensure compliance with quality standards. The role involves collaboration in a dynamic team, focusing on innovative solutions for medical devices. Candidates should possess a strong engineering background and excellent communication skills in both English and German.

Qualifikationen

• Deep knowledge of quality system regulation (QSR, ISO 13485).
• At least 1 year of experience in a highly regulated industry.
• Good communication skills in English and German.

Aufgaben

• Support New Product Development projects and risk management deliverables.
• Evaluate end user needs and generate design requirements.
• Test and analyze engineering prototypes using statistical tools.

Kenntnisse

Communication

Problem Solving

Statistical Analysis

Ausbildung

Bachelor's degree in engineering or scientific discipline

Advanced degree

Jobbeschreibung

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com.

Job Function: Quality

Job Sub Function: R&D / Scientific Quality

Job Category: Professional

All Job Posting Locations: DE029 Aachen

Job Description

ABIOMED is redefining team-driven success while reshaping heart recovery. Here, new ideas are welcomed and encouraged, learning is constant, and our dynamic setting enables positive people to do profoundly important work. The ideal candidate for the Quality Engineer position will lead various New Product Development and sustaining activities, play a role in product risk management, change controls, and design controls. This engineer should excel in an environment that embraces teamwork, change, risk-based decision-making, and flexibility. Be ready to make a significant contribution to a dynamic, fun, multi-disciplinary team, where a self-motivated engineer with excellent communication skills stands ready to succeed. Join our Abiomed team today!

Principle Duties and Responsibilities

1. Support New Product Development projects Risk Management Deliverables
2. Use technical expertise to rapidly innovate medical devices for chronic heart failure patients.
3. Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets, including design for manufacturing, assembly, and automation.
4. Develop and review test protocols, reports, and engineering summaries.
5. Perform process development studies in collaboration with manufacturing teammates, focusing on design solutions that enable manufacturability internally and at external suppliers.
6. Test and analyze engineering prototypes using statistical analysis tools like Minitab, applying techniques such as multivariate charts, t-tests, and gauge R&R to iterate towards innovative and robust solutions.
7. Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
8. Lead multidisciplinary projects and processes.
9. Support escalations and conduct technical investigations.
10. Contribute to the success of the Quality System performance measures by completing tasks on time with high quality.
11. Support CAPA activities and manage the CAPA system as necessary.
12. Support 3rd party audits, including follow-up on actions.
13. Ensure compliance of QMS through authoring and updating SOPs.

Job Qualifications

1. Deep knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP, and MDD / MDR.
2. Working knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971.
3. Bachelor's degree in engineering or scientific discipline; an advanced degree is a plus.
4. At least 1 year of experience in a highly regulated industry or an equivalent master's degree.
5. Good communication skills in English and German.
6. Experience with FMEA, process validation, and blueprint reading (GD&T) is preferred.
7. This position is based in Aachen, Germany, requiring on-site presence 3-4 days a week and 10% travel.