Our client, a biotech company based in greater Dublin, have an outstanding track record of innovation in their specialist therapeutic sector. This program-based role is a unique opportunity at a development-stage company, being a key contributor to a highly experienced technical/operational team. This role will require highly talented engineer to participate in the development of next generation of medicine.
The successful candidate will provide high quality engineering and design support to the Technical Operations team. The Principal Design Engineer will be the primary liaison on engineering and design projects between company Technical Operations and external partners.
The ideal candidate will be action-oriented and a key team member with a strong industry experience of design engineering. Candidates must be experienced in leading NPD / NPI project activities in industry, while working with vendors on outsourced activities in compliance with regulatory approvals to commercial product launch.
Responsibilities for Principal Design Engineer:
- Lead the technical and engineering aspects projects with external development and manufacturing partners ranging from prototyping runs to commercial scale manufacture.
- Design and develop solutions for challenges across the spectrum of technologies through design process.
- Translate company requirements into specifications and ensure appropriate stress testing of design solutions for breadth of application and robustness.
- Build compliance in early to designs. This includes compliance with typical electrical, mechanical, automation and regulatory standards for multiple geographies.
- Represent company in design decisions and ensure all designs and solution consider “DOE”. Providing technical guidance on all areas of design.
- Own project deliverables and work packages and work in tandem with Project and Vendor Management to ensure delivery on time, in full and on budget.
- Develop and/or approve manuals, SOP’s, design briefs, technical reports, test strategies, test
- protocols, specifications etc, on behalf of company.
- Participate in execution of any required testing at company or appropriate external partner site.
- Identifying suppliers for materials, components and subassemblies as required.
- Supporting qualification of new suppliers or partners including on-site visits and supplier audits.
- Provide timely, accurate and concise summaries and project reviews to the Senior Leadership Team.
Requirements for Principal Design Engineer:
- Degree level qualification in Product/Mechanical/Manufacturing/Biomedical Engineering or other related discipline.
- 10+ years industry experience, 3+ years of which in Medical Devices, Pharmaceuticals or Biotech industries. Alternatively experience in other highly regulated industry may suffice.
- 2+ years in Senior Engineer roles, with demonstrated history of leading projects with internal and external team members
- Excellent communication skills and written and oral.
- Lean, Agile or Scrum qualifications an advantage
- Experience with Solid Edge design software
Expertise Required for this role:
- Creative individual who can develop product solutions lead implementation of solutions
- Knowledge of 3D printing, Injection moulding, prototyping and design for manufacture
- Self-starter capable of identifying opportunities
- Knowledge atomisation or spraying technologies
- Familiarity with GMP and regulatory processes
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.