Systems Engineer, Product Development – Life Sciences

• Guide multidisciplinary technical teams to drive product development programmes and deliver successful client outcomes.
• Present as a trusted technical face of the in vitro diagnostics and life science tools sector to clients.
• Collaborate with sector business developers in the EU and USA to bring in sales opportunities.
• Lead multidisciplinary teams of technical experts in the UK and USA through the technical complexities of development projects.
• Ensure products meet requirements.
• Oversee delivery of client projects to a high level of technical quality.
• Lead projects where required, communicating and meeting with clients regularly.
• Mentor and develop team knowledge, skills and experience in in vitro diagnostics and life science tools.
• Nurture internal Diagnostics sector technical specialists and recruit externally.
• Work with client managers to nurture and develop long-term client relationships.
• Raise the sector’s public profile globally by attending conferences.
• Travel internationally for client visits, conferences, and visits to the Raleigh, USA office.
• Perform other duties as assigned.

Requirements

• Expert knowledge in the in vitro diagnostics and life sciences market, able to understand specialist technologies and applications to help identify compelling opportunities for CDP and clients.
• Expert at designing systems that implement complex biochemical assays; able to navigate the technical, user and cost trade-offs to develop ‘well balanced’ products.
• Leadership and communication skills to empower the team and drive multidisciplinary development projects efficiently and effectively towards well-defined goals.
• Creative and highly technical ability in many of the following areas: concept generation of consumables and reader systems; assay implementation, prototyping techniques, detail design; design of experiments; design for high volume manufacture, IVD V&V.
• Familiar with industry regulations IVDR, MDR and standards ISO 13485, 21CFR part 820 and ISO14971.
• Comfortable presenting to clients and groups, with confident, clear and compelling communication style.
• Confident working in a fast-paced consultancy environment.
• Career experience in medical device development, ideally having played a significant role in product launch of an in vitro diagnostic device or life science tools product. Alternatively, experience at a product /technology development consultancy working in the same field.
• Track record of planning and leading large development projects, taking responsibility for quality, time, and cost.
• Proven experience in account management activities, acting as technical lead in sales meetings, proposal writing and presenting.
• Degree-level education, or equivalent in relevant subject such as Mechanical Engineering, Physics or Natural Sciences.

Core Competencies

Demonstrates expert knowledge in the in vitro diagnostics and life sciences market, with a strong ability to design systems for complex biochemical assays and lead multidisciplinary development projects. Proven track record in account management, client relationship development, and adherence to industry regulations.

Highest-signal resume keywords

• In Vitro Diagnostics Expertise
• Biochemical Assay Design
• Leadership in Multidisciplinary Projects
• Account Management Experience
• Familiarity with IVDR and MDR Regulations

Hard Skills

• System Design for Biochemical Assays
• Assay Implementation
• Prototyping Techniques
• Design of Experiments
• Design for High Volume Manufacture
• IVD Verification and Validation
• Project Planning and Leadership
• Technical Proposal Writing
• Product Launch Experience
• Technical Sales Presentations

Soft Skills

• Leadership Skills
• Effective Communication
• Team Mentoring
• Client Relationship Management
• Creative Problem Solving

Industry Keywords

• Life Science Tools
• ISO 13485
• 21CFR Part 820
• ISO 14971
• Medical Device Development
• Consultancy Environment
• Multidisciplinary Teams
• Client Outcomes
• Technical Quality Assurance
• Public Profile Development