• 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.

• 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 you're interested in this role, click 'apply now' 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.