Medical Device Design Control Process Specialist (m/f/d)


Medizin & Pharma

Your responsibility

  • Define, optimize, and document Haselmeier’s medical device design control process
  • Train and educate employees in the use of design controls
  • Establish a platform strategy for device documentation
  • Present and defend the process to customers and during audits
  • Support the team in the creation of a high-quality design history file
  • Ensure PLM system is aligned to the design control process
  • Plan and execute improvements to the PLM system
  • Interface with cross-departmental teams to ensure processes are coordinated

What we offer

  • Working in highly motivated, international teams
  • Dedicated people who put the needs of patients at the center of their doing
  • Performance-based salary, attractive benefits and a flexible and modern working environment

What you offer

  • Completed studies in the technical field
  • Expert knowledge and practical experience in the use of Medical Device Design Control and Combination Products regulations (21 CFR 820, 21 CFR 4, ISO 13485, EU MDR, etc) and best practices
  • Experience working with PLM systems, Aras Innovator / Minerva PLM preferred
  • Basic understanding of product development
  • Ideally proficient in German and English, both written and spoken
  • Motivated team player, flexible, high level of problem-solving skills, self-initiative, and independence

Who we are

Haselmeier, a part of Sulzer AG, has been established in the healthcare marketplace for over 100 years. With approximately 240 employees, Haselmeier has been pioneering the development of injection pens for subcutaneous application since the 1960s. We continue to drive innovation in self-injection pens from design and manufacturing to packaging and delivery. We have developed solutions in scalable volumes for numerous pharmaceutical partners, always following state-of-the-art engineering practices - and we aim to evolve even further. We design our products with a patient-centric approach. Our injection devices are used in a variety of therapeutic areas, helping patients living with diabetes, supporting fertility treatment and even being an option for low-impact cancer therapy.

Join us to impact the world of healthcare

If you are looking for an exciting job in a growing company with pleasant atmosphere and short distances, then apply!

Do you have any questions?
Please call us.

Sabine Hufschmitt | +49 711 71978-174

Wilhelm Haselmeier
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