Technical Documentation & Development Engineer; Medical Devices

Role Description

Harvest Healthcare is seeking a Technical Documentation & Development Engineer to support the documentation, CAD formalisation, and regulatory requirements of product development within the healthcare sector. This role is primarily focused on documentation, compliance, and technical file management. It supports hands‑on product development activities led by the NPD/EPD Engineer but does not lead physical product development. The role ensures that all development activities, both new and legacy, are fully documented, structured, and compliant with Medical Device Regulation (MDR) and internal gated development processes.

A significant focus of the role will be bringing legacy products up to current documentation and CAD standards.

• Responsibilities will include, but not limited to the following:
• Produce and maintain development documentation in accordance with MDR
• Administer building and maintaining technical files for existing and new products
  • Take ownership of legacy product documentation, including reverse engineering and CAD generation
• Create CAD drawings based on existing products, prototypes, and development direction provided by members of the development team
  • Ensure all drawings are production‑ready and controlled under revision systems
• Document design changes, improvements, and development activities
  • Regulatory Compliance:
    Ensuring that design changes comply with relevant medical device regulations, standards, and certifications.
  • Ensure documentation is organized and maintained to support regulatory compliance
• Ensure all development stages meet documentation requirements before progression (gated process)
• Support risk management and design documentation processes
• Value Engineering:
  Collaborating with the Procurement and Supply Chain teams to identify cost‑effective solutions without compromising product quality.
• Collaboration and Communication:
  Effectively communicating with cross‑functional teams, including R&D, Manufacturing, Regulatory Affairs, Sales and Marketing, to ensure seamless integration of design updates and improvements. Support Production with all technical queries.
• ECR (Change Control):
  Carry out ECR tasks such as drawing or specification updates when required.

• Experience preparing technical documentation for medical devices
• Strong understanding of MDR and regulated development environments
• Strong CAD skills (Solid Works or similar)
• Experience with Technical Files, DHF, and change control systems
• High attention to detail and structured working approach

• Technically minded:
  The applicant should be of a technical nature.
• Attention to detail:
  Precision and attention to detail are critical.
• Communication skills:
  Excellent written and verbal skills required. Applicant will collaborate with a variety of different teams, including manufacturing, purchasing, Sales and R&D.
• Adaptability:
  Being adaptable and open to revising designs or approaches is vital to achieving the best possible outcome.
• Time management:
  Good time management skills required to stay organized, meet milestones, and deliver results efficiently.
• Team player:
  Ability to collaborate with cross‑functional teams, including marketing, engineering, and manufacturing. Being a team player but also being able to work independently.
• Ethical and responsible:
  Product design engineers should consider the ethical implications of their designs, such as safety, environmental impact, and social responsibility.
• Self‑motivated: flexible, proactive and committed.

• Higher National Diploma (HND) in Engineering, Product Design, or a related field (Minimum)
• 5 years’ minimum experience in Technical engineering role for Medical Device products/production. Product development management experience is a plus.
• Experience of creating drawings is Essential for this role.
• This role requires experience working within a regulated product development environment, ideally within the medical device sector.
• Experience in preparing and maintaining technical documentation in accordance with Medical Device Regulation (MDR) requirements. This includes experience in working on /…