Systems Engineer, Product Development – Life Sciences

Jobtailor; Cambridge; On-site; GBP 90,000 - 130,000; Full time

Job summary

Jobtailor is seeking a senior leader to guide multidisciplinary technical teams in the in vitro diagnostics and life science tools sector. You will drive development programmes, present to clients, and collaborate with global teams to secure opportunities.

The role requires deep domain expertise, leadership and a track record in product launches or technology development consulting within this field. Travel may be international.

Qualifications

• Expert knowledge in in vitro diagnostics and life sciences market.
• Ability to design systems for complex biochemical assays with trade-offs.
• Leadership and communication to drive multidisciplinary development projects.
• Proficiency in concept generation, prototyping, design of experiments and high-volume manufacturing.
• Familiarity with IVDR, MDR and ISO 13485, 21 CFR 820, ISO 14971.

Responsibilities

• Guide multidisciplinary technical teams to drive product development programmes and deliver client outcomes.
• Present as a trusted technical face to clients in in vitro diagnostics and life science tools.
• Collaborate with sector business developers to bring in sales opportunities.
• Lead multidisciplinary teams through technical complexities of development projects.
• Ensure products meet requirements and maintain high technical quality.

Skills

Leadership

Effective communication

Account management

Project leadership

Client relationship management

Creative problem solving

Education

Degree-level education in Mechanical Engineering or Physics or Natural Sciences

Job description

• 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