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.
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/.
The ideal candidate for the Quality Engineer position will lead various New Product Development and sustaining activities as well as 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 written and verbal communication skills stands ready to succeed.
Seize the opportunity today to join this collaborative, high performing team within the fastest growing business in MedTech. Come join our Abiomed team today!
Principle Duties and Responsibilities:
- Support New Product Development projects Risk Management Deliverables
- Use technical expertise, knowledge, and experience to rapidly innovate the companies’ medical devices for use in chronic heart failure patients.
- Evaluate end user needs, standards requirements, and risk evaluations to generate design requirements and engineering targets which include design for manufacturing, assembly, and automation.
- Develop and/or review test protocols, reports, and engineering summaries
- Perform process development studies in collaboration with MFG teammates and bring an open mind to design solutions which enable manufacturability internally and at external suppliers.
- Test, and analyze engineering prototypes using statistical analysis in Minitab and apply to the design effort (Multivar chart, t-tests, confidence/reliably analysis, Gauge R&R) to iterate concepts toward extremely innovative yet robust solutions.
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues as related to the position responsibilities.
- Lead multidisciplinary projects and processes
- Support escalations and conduct technical investigations
- Contribute to the success of the Quality System performance measures by completing tasks on time and with a high level of Quality
- Provide support during Corrective and Preventive Action (CAPA) activities and manage the CAPA system as necessary.
- Support 3rd party audits, including follow-up on actions.
- Ensure compliance of QMS through authoring and updating Standard Operating Procedures (SOP).
Job Qualifications:
- Must have in depth knowledge of and ability to apply quality system regulation, including QSR, ISO 13485, MDSAP and MDD/MDR.
- Working knowledge and practical application of 21 CFR Part 820, ISO 13485, and ISO 14971 is required.
- A minimum of a Bachelor's degree in an engineering or scientific discipline is required. An advanced degree in a related field is also an asset.
- 1+ years of work experience in a highly regulated industry is required or equivalent masters degree in engineering or scientific discipline. Medical Device and/or Pharmaceutical industry is preferred.
- Good communication skills, both verbal and written in English and German
- Experience conducting Process / Design Failure Mode Effects and Analysis is an asset.
- Design control or new product development is preferred.
- Experience supporting or conducting Process Verification / Validation activities is preferred.
- Experience with Blueprint reading/literacy including GD&T is preferred. Familiarity with inspection methods and techniques is an asset.
This position will be based in Aachen, Germany with a requirement to be on-site 3-4 days per week and will require 10% travel.
Abiomed is an Equal Opportunity Employer committed to a diverse workforce. Abiomed will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, gender identity, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law. Abiomed maintains a drug-free workplace.