Blank
Aan de slag
Blank
Carrièrekansen
Terug naar functiezoekopdracht

Moulding Expert; Technical SME for Product Transfer Activities

  • Locatie:

    Denemarcken

  • Contactpersoon:

    Dave Twomey

  • Contractsoorten:

    Contract

  • Telefoon contactpersoon:

    +353 21 4857 284

  • Bedrijfssectoren:

    Medical Device & Diagnostics

  • E-mail contactpersoon:

    dave_twomey@oxfordcorp.com

Our Danish client is seeking a Moulding Expert to join a team of Subject Matter Experts (SMEs) supporting the transfer of commercial-stage products to vendors/CMOs across Europe, China, and the US. This position is part of a new SME team based in Denmark, focusing on product transfer, troubleshooting, and ensuring the technical success of these activities.

Key Responsibilities:

  • Act as the technical SME for moulding processes during the transfer of products to external vendors/CMOs.
  • Review, design, and resolve complex tooling and moulding issues, ensuring alignment with high-complexity product requirements (e.g., assemblies of 5-10 moulded components).
  • Support CMOs in meeting GMP standards and ensure a smooth transfer process, addressing challenges and troubleshooting in real time.
  • Take ownership of technical content, such as specification packages, drawings, procedures, protocols, and processes, and act as the first point of communication for CMO sites.
  • Provide technical guidance to CMOs, ensuring their readiness for product transfers and addressing complex technical questions.
  • Leverage internal SME networks for escalation and support when necessary.
  • Work collaboratively with CMOs, internal teams, and stakeholders to ensure successful outcomes.

Requirements:

Experience:
10+ years of hands-on experience in moulding processes at a mid-senior level. Demonstrable experience in executing similar transfer activities within the last 2-4 years, ensuring familiarity with the latest technologies and regulatory environments.

Technical Skills:
Proven expertise in reviewing and designing tools for complex moulding processes.
Ability to troubleshoot and resolve advanced moulding challenges.
Experience with highly complex assemblies (5-10 moulded components); candidates with experience in simpler assemblies (2-3 components) will not meet the criteria.
Industry Knowledge:
Strong background in Medtech and ISO 13485 compliance is essential. Experience with drug delivery systems and autoinjectors is a significant advantage.
Communication:
Excellent English language skills, both written and verbal.
Vendor Knowledge:
Prior experience with the client's vendors is a strong plus (specific vendors to be disclosed upon confirmation).
Regulatory Understanding:
Strong knowledge of GMP standards and a proactive approach to ensuring compliance at CMO sites

Additional Information:

  • The position will involve working closely with international CMOs, some of which may not currently meet GMP standards.
  • This is a contractor role requiring on-site work in Denmark, with collaboration across global stakeholders.
  • Candidates must demonstrate a proactive and problem-solving mindset to handle the complexities of the transfer process.

Location: Denmark
Contract Type: Contractor
Start Date: Immediate availability preferred

If you're a moulding expert with the technical expertise and experience to lead high-complexity product transfers in a regulated environment, we encourage you to apply!