Senior Integration Specialist
2 dni temu
Ready to lead innovation in clinical diagnostics?
Take charge of integrating and verifying new diagnostic products as a Senior Systems Integration Engineer. Define test cycles, develop methods, and report results. Your expertise in engineering and clinical applications will be crucial for developing products across molecular diagnostics, clinical immunology, and immunohematology.
Collaborate with multidisciplinary teams to ensure that product design meets the highest standards of quality, reliability, and functionality. Guide the team working on new and sustaining projects, ensuring safe and compliant solutions.
Key Responsibilities:
- Develop and execute system design integration and verification plans for new medical diagnostics devices, including defining test cycles and strategies.
- Create test protocols to support continuous integration design and manage risk.
- Oversee test execution for the device and its subsystems, including managing personnel, equipment, and vendor partnerships.
- Report test outcomes with clear evidence to inform technical decisions and regulatory submissions.
- Ensure traceability of evidence throughout the product development lifecycle.
- Promote best practices and improvements in system design integration and verification.
- Utilize global resources to optimize testing activities.
- Provide technical leadership in developing reliable and cost-effective test methods involving various technologies.
- Potentially lead a systems integration and verification team and manage engineering deliverables.
We're Looking for:
- BS in Engineering, MS, PhD, or MBA is a plus.
- 10+ years in developing complex integrated systems, preferably in life sciences or diagnostics, with a track record of successful products.
- 5+ years hands-on laboratory testing with various scientific tools and methods.
- 3+ years in managing and developing engineering teams.
- Good command of English is a must.
- Experience in regulated industries with knowledge of relevant regulations and risk management (ideally with IVD experience, QSR/ISO regulations (e.g., ISO 13485, IEC 62304) & standards and risk management (ISO14971)).
- Strong problem-solving, organizational, and analytical skills; adept at managing risks and adapting to dynamic environments.
- DFSS Green or Black Belt certification is a plus.
- Familiarity with SDLC, agile methodologies, CI/CD practices, and proficiency in Python or Matlab.
- Strong problem-solving skills and attention to detail.
- Excellent communication skills and ability to work collaboratively in a team environment.
- Eligibility to work in Poland.
We Offer:
- Your salary will be highly correlated with your skills and mindset: from 26.000 up to 30.000+ gross PLN Employment Contract.
- Hybrid model of work: Mon and Fri on-line and Tue, Wed, Thu – in a comfortable office in Warsaw.
- Participating in the newest technology solutions, classified products and services.
- Exciting and challenging projects.
- Being part of an ambitious company with a lot of growth opportunities awarded with Great Place to Work 2023.
- Waking up in the morning knowing you are making a difference.
- Working in an agile culture with exposure to international environment.
Recruitment Process:
- Send your CV via H4H form or email: biuro@h4h.com.pl.
- 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 if we have some better job offers for you.
- 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.
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