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R&D Team Coordinator - Design Controls

HAYS

Poznan, wielkopolskie

Opis stanowiska pracy

R&D Team Coordinator - Design Controls
Poznan
NR REF.: 1189446

We are looking for skilled Team Leader to manage Design Control Specialists, ensuring our new product development aligns with business goals, regulatory requirements, and top-quality standards. Our Client is located in Poznań. 
Key Responsibilities:
  • Leadership & Team Management: Lead and support a team of Design Control Specialists, ensuring they have the guidance and resources needed to succeed in both new product development and sustaining current products.
  • Business Strategy Alignment: Collaborate with cross-functional teams to ensure product development aligns with business objectives, market needs, and customer requirements.
  • Product Development Expertise: Oversee design control processes throughout the product lifecycle, with a focus on bringing innovative new products to market. Lead the creation and management of design inputs, outputs, and verification/validation plans.
  • Risk Management & Usability: Oversee risk management and usability engineering activities, ensuring comprehensive evaluations are completed to ensure the safety, effectiveness, and user experience of new products..
  • Regulatory Compliance: Ensure all development activities are in full compliance with relevant international regulations (e.g., ISO 13485, FDA 21 CFR 820.30, MDR 2017/745, ISO 14971).
  • Documentation & Reporting: Oversee the preparation of design documentation for regulatory submissions and internal review, and ensure timely reporting to both line managers and project leaders.
  • Cross-Functional Collaboration: Work closely with key stakeholders, including R&D project teams, clinical experts, regulatory officers, and suppliers, to ensure alignment of technical and business strategies.
  • Continuous Improvement: Encourage a culture of innovation and quality improvement within the team, fostering new ideas for product development and lifecycle management.

Requirements:
  • Experience:
    • Minimum 7 years’ experience in medical device design control, with at least 2 years in a leadership role.
    • Proven track record in overseeing new product development from concept through commercialization.
  • Business Acumen: Strong understanding of the commercial and strategic implications of product development decisions, with the ability to balance regulatory and business priorities.
  • Expertise:
    • Proficiency in design control processes, risk management, and usability engineering.
    • Familiarity with international standards and regulations (ISO 13485, FDA 21 CFR 820.30, MDR 2017/745, ISO 14971).
  • Leadership & Communication: Ability to lead a team, set performance expectations, and communicate clearly across departments. Fluent in English (≥ B2 level).
  • Organizational Skills: Excellent project management skills, with a focus on efficiency and timely delivery of high-quality products.


If you39re interested in this role, click 39apply now39 to forward an up-to-date copy of your CV, or call us now.



Hays Poland sp. z o.o. is an employment agency registered in a registry kept by Marshal of the Mazowieckie Voivodeship under the number 361.

Prezentacja firmy

HAYS Poland jest firmą doradztwa personalnego, należącą do międzynarodow... Rozwiń

Dodatkowe informacje

Ostatnia aktualizacja:
21/11/2024
Wymiar etatu:
Pełny etat
Rodzaj umowy:
Na czas nieokreślony
Liczba wakatów:
1
Min. doświadczenie:
1 rok
Min. wykształcenie:
Policealne
Branża / kategoria:
Praca BHP / Ochrona środowiska

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