Technical Documentation & Development Engineer (Medical Devices) in Wakefield

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.

Key Responsibilities

• 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.
• Ensure 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.
• Collaborate with the Procurement and Supply Chain teams to identify cost‑effective solutions without compromising product quality.
• Effectively communicate 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.
• Carry out ECR tasks such as drawing or specification updates when required.

Essential Skills

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

Personal Characteristics

• 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.
• 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.
• 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.

Education & Experience

• 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.
• Experience contributing to Design History Files (DHF), risk management documentation, verification and validation records, or similar regulated development documentation would be highly beneficial.
• Strong technical foundation and other relevant engineering tools.
• Proficient in Microsoft Office applications: PowerPoint, Word and particularly Excel.
• Familiarity with risk analysis techniques, medical device regulations, and standards is a plus.
• Strong analytical and problem‑solving abilities to identify issues and propose effective solutions.
• Demonstrated ability to work effectively in cross‑functional teams and communicate complex ideas concisely.
• Meticulousness in product analysis, documentation, and compliance with medical device regulations.
• Adherent to addressing complex issues efficiently and effectively.
• Effective communication and collaboration skills: able to effectively convey ideas, actively listen, and work well with others to achieve common goals.

Join Harvest Healthcare as a Technical Documentation & Development Engineer (Medical Devices) and contribute to our mission of improving patient care and outcomes through continuous improvement and optimization of our existing medical product portfolio.