Validation Engineer

2 tygodni temu

Kraków, Lesser Poland Human4Human Recruitment Pełny etat

Our Partner is a leading company specializing in the production of medical implants, dedicated to improving the quality of life for patients worldwide. Their commitment to innovation and excellence has established us as a prominent player in the medical device industry. We are seeking a skilled and experienced Validation Engineer to join our team and contribute to the advancement of medical implant technologies.

Validation Engineer (Medical products)

You will be responsible for:

  • Interpreting and guiding on regulations, standards, and validation processes in manufacturing medical devices,
  • Developing validation procedures with the Corporate Validation Team,
  • Becoming a Subject Matter Expert (SME) in multiple validation specialties,
  • Advising on process improvement and validation strategies,
  • Crafting validation plans, protocols, and reports (IQ, OQ, PQ),
  • Coordinating with stakeholders for unified validation procedures,
  • Addressing out-of-spec results and proposing fixes,
  • Applying validation principles across processes, equipment, and methods,
  • Supporting validated state through work instructions and risk analysis,
  • Delivering technical presentations to stakeholders.

We require:

  • Bachelor's or Master's degree in Mechanical Engineering or related field,
  • At least 3 years of experience in validation engineering,
  • Fluency in English,
  • Any experience in the medical or healthcare industry (must have),
  • Strong grasp of regulations, standards, and validation,
  • Proven skill in creating/validation plans, protocols, reports,
  • Excellent communication and analytical skills,
  • ISO 13485 familiarity a plus.

We offer:

  • Your salary will be highly correlated with your skills and mindset: from up to gross PLN,
  • Participating it the newest technology solutions, classified products and services,
  • A company culture based on autonomy, high-trust & accountability,
  • Full – time permanent contract of employment,
  • PPK – employee pension program,
  • Lux Med – private medical care for employees and family members,
  • Exciting and Challenging Projects,
  • Collaborative and Dynamic Environment,
  • Being part of an ambitious company with a lot of growth opportunities awarded with Great Place to Work 2023,
  • Playing a crucial role in the development team,
  • Waking up in the morning knowing you are making a difference,
  • Working in an agile culture with exposure to international environment,
  • Hot & cold beverages,
  • Fruits & snacks,
  • Shower & bike parking,
  • Chill room and playroom for children,
  • Integration events.

Recruitment process steps:

  • Send your CV via H4H form or email:
  • A 10-20 minutes phone call with H4H IT Consultant to enrich your application with missing details.
  • A 15-30 minutes video call with our Partner's Tech Leader, to evaluate your skills. We may redo it whether we have some better job offers for you.
  • A 15-30 minutes video call with end Client representatives - automotive component manufacturing company to ensure good understanding of the role for your side and enable you to ask any questions regarding your new role.
  • A short video-call or phone call with our Partner's HR Business Partner to check in depth the alignment between you and values and culture of the Company. Financial negotiations are welcomed :)
  • Welcome aboard

About our recruitment process:

Our recruitment process is tailored to do our best to avoid that you or we realize that we're not a perfect fit in two or six months. It might seem long, but every step serves a purpose and will allow us to get to know you better as much as it'll help you understand more where you'll be stepping in.

We also want you to have time to ask all your questions regarding your job description, the long-term vision of your team and the company, our values, with the relevant interlocutor in front of you.

The steps mentioned above can be rearranged depending on yours and the interviewer's availability.

How to nail your application:

  • Tailor your CV & application to our specific job description and company. Attention to detail is important as an employee as it is as an applicant
  • Complete the different steps of the application process in a timely manner, to ensure you don't miss out on this opportunity
  • Help us synchronize your availability with our Managers' calendars to fulfil the video calls.
  • Prepare your interviews and the questions you will ask at each step, depending on who's conducting it.
  • Any copy-pasted or non-personalized application will not be considered.
  • Non-UE citizens will not be considered due to project requirements.

Direct contact to our TA Specialist:

Albert: tel.: ,

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