Device & Combination Product Development Expert

Reference Number: 896055-W
Type of placement: Permanent
Location: Switzerland, North West

Introduction:

Our client is a public Swiss Specialty Pharma company listed on the SIX Swiss Stock Exchange focusing on the discovery and development of macrocycle drugs addressing high unmet medical needs. These macrocycles represent a new drug class complementary to the classical small molecules and large biopharmaceuticals. They are currently looking for a Device & Combination Product Development Expert

Main Responsibilities:

  • Accountable and responsible for technical product development from concept to market launch to meet business objectives.
  • Provide sound technical & engineering expertise to develop new product and timely address technical resolution for devices, combination product and packaging, and ensure end to end robustness of developed products.
  • Execute all Design Development and Engineering activities & tasks defined for the product including GMP technical documentation management, support to Regulatory filings and maintaining inspection readiness.
  • Design Product & Lead technical activities internally, with suppliers and service providers
  • Responsible for the development, implementation and validation of all test methods required to effectively characterize products.
  • Effectively collaborate with all project functions and communicate technical equipment requirement for industrialization of the product.
  • Maintain an overview of state-of-the-art technology development within the related business, and Participate in the evaluation and assessment of products, processes and suppliers for new product
  • Ensure compliance with all local, state, federal, and internal company quality policies, procedures and practices, safety regulations, policies, and procedures.   

Qualifications and Experience:

  • Undergraduate degree in related engineering field, advanced degree desired.
  • Minimum 7 years of experience in engineering/technical field, with 5 years demonstrated product development in medical or pharmaceutical industry with successful track record of delivering products to market.
  • Demonstrated medical device, combination product and packaging development technical skills.
  • Sound statistical knowledge and associated system (e.g. minitab).
  • Broad and deep understanding of disciplined product development processes, regulatory, and quality requirements.
  • Ability to use Computer Aided Design (CAD) system. (e.g SolidWorks…)
  • Strong skills in project planning and management
  • Experience in leading a team
  • Fluency in English
  • Relevant working/residency permit or Swiss/EU-Citizenship required

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