Our client is a multinational biopharmaceutical company with an outstanding track record of innovation in their specialist therapeutic sector. This newly created role is a unique opportunity at a well-funded start-up, with field-leading advisors, and a highly experienced technical/operational team.
Our client is looking for a talented, experienced Senior Design Engineer to join their team as a key contributor in a key program-based role supporting internal and external Cell Therapy programs. Reporting directly to the Director of Process Engineering the Senior Design Engineer will provide high quality engineering and design support to the Technical Operations team. The ideal candidate will be action-oriented and a key team member with a strong understanding of design engineering space, comfortable assembling equipment with electronic components.
- Lead design activities throughout the entire product life cycle from concept to specifications to prototyping, commercialisation and retiring.
- Lead and participate in common engineering risk workshops including safety risk assessments and dFMEAs.
- Draft and maintain engineering related protocols and work instructions in line with the QMS.
- Develop and review technical documentation in compliance with the QMS including CAD, drawings, manuals, SOP’s, design briefs, technical reports, test strategies, test protocols, specifications etc.
- Build and maintain design history files for technologies.
- Lead engineering activities and liaise with appointed contract and development manufacturing organisations (CDMOs).
- Design and develop prototype solutions for challenges across the spectrum of technologies.
- Incorporate existing knowledge from into appropriate aspects of design.
- Build instruments in compliance with international medical, electrical and mechanical standards.
- Design engineering experiments to test design performance using statistical methods and software.
- Represent in design decisions (internally and with CDMOs) and ensure all designs and solutions consider “design for manufacture”.
- Provide technical guidance to colleagues and on all areas of a design.
- Communicate design decisions, progress and impact to other colleagues.
- Own project deliverables and work packages, working in tandem with Project and Vendor Management to ensure delivery on time, in full and on budget.
- Conduct installation, commissioning, and qualification of technologies internally and externally at partner sites or appointed CDMOs.
- Identifying suppliers for materials, components and subassemblies as required.
- Design and implement jigs and test rigs to aid in product development and testing
- Support and enhance the design documentation process at and ensure appropriate level of documentation is supported by and transferred from external partners and CDMOs.
- Operate in a team environment, assume leadership roles in cross functional teams.
- Provide timely, accurate and concise summaries and project reviews to the Director of Process Engineering.
- Degree level qualification in Product, Mechanical, Manufacturing, Mechatronic or Biomedical Engineering.
- 7-9 years post graduate experience with 5 years in a regulated industry such as Medical Devices, Pharmaceuticals or Biotech. Experience in another highly regulated industry will also be considered.
- Strong understanding of regulated documentation systems aligned with ISO13485.
- Demonstrated history of product design and prototyping ideally with electronic and pneumatic elements.
- Comfortable working with common engineering measurement tools such as oscilloscopes, DAQ systems multi-meters, transducers and manometers.
- Experience using PLCs and ladder logic an advantage.
- Strong experience with common product design and CAD software; ideally Solid Edge, photoshop and Illustrator.
- Demonstrated history of instrument qualification (FAT, IQ, OQ and PQ) as well as Verification and Validation.
- Experience using and knowledge of statistical packages to design experiments, ideally Minitab.
- Experience designing products to international standards (EN IEC 61010, 60204, 60601) for CE marking.
- Experience working in compliance with a Quality Management System and the capability to draft documents at the appropriate level (SOP, WI etc).
- Experience building and maintaining technical regulatory documents including design history files.
- Knowledge of injection moulding highly desirable.
- Experience with basic computer programming for task and data analysis automation desirable, for example Excel VBA or Matlab.
- Demonstrated history of leading technical aspects of a project both internally and with external partners.
- Excellent communication skills and demonstrated experience of liaising with external vendors and clients.
- Familiarity with GMP qualification of equipment.
- Travel externally to appointed CDMOs, suppliers or partners to conduct technical audits
Gerry Kennedy, Managing Director, Recruitment for Technology Ltd.