Senior Device Development Engineer at SMC Ltd.

South Cambridgeshire, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

18 May, 26

Salary

0.0

Posted On

17 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Design Leadership, Device Development, Autoinjector Platforms, Functional Performance, Manufacturability, Regulatory Standards, Human Factors Engineering, Quality Assurance, Design Control, Intellectual Property, Test Plan Preparation, Supplier Management, Risk Assessment, SolidWorks, ISO 13485, FDA Regulations

Industry

Automation Machinery Manufacturing

Description

SMC Pharma Services Ltd is seeking an experienced design engineer to join our small but growing Device Development team working on our range of autoinjector platforms. The main purpose of the role will be to lead device development programmes that meet the necessary functional performance, manufacturability and commercial requirements, whilst adhering to regulatory standards, according to development timescales and costs that meet business plans and needs. This role will work collaboratively with human factors engineers, quality assurance, and manufacturing teams to ensure successful product development and commercialization. We are particularly keen to hear from candidates with experience of compliance with relevant standards for combination product and/or regulatory submission. Key responsibilities are as follows: Technical Leadership * Supporting the technical leadership of the design and development of drug delivery devices from concept to commercialisation. This includes: - * Identification and protection of IP * Ensuring engineering specifications meet customer needs, align with regulatory expectations and are suitable for verification and validation. * Appraisal of designs to ensure that functional performance is achieved, manufacturability is robust and regulatory standards are met * Design Control - Ensure that all project inputs and outputs are thoroughly documented, providing a robust and detailed design history file for device developments, acting as a role model for other members of staff in terms of the quality of documentation produced. * Represent the company at external events, providing presentations and articles for publication. Device Design and Combination Product Development * Preparation and implementation of test plans to demonstrate performance, reliability, and safety of drug delivery devices. * Supplier Management - Assess, select and work closely with suppliers to select components, ensure quality, and manage the manufacturing of drug delivery devices. * Represent the company in customer meetings as required. Regulatory Compliance * Ensure that all device development activities are compliant with relevant regulatory standards, such as ISO 13485 and FDA regulations. Collaborate with client regulatory affairs teams to support submissions. About You We are seeking candidates with the following: * Experience in design and development of drug delivery systems * A strong background in design, development and validation of injection moulded components * Experience in the development of intricate but robust mechanisms * Experience in risk assessment and risk management. * Experience in working with customers. * Skilled in the use of CAD tools, ideally SolidWorks * Experience of US and EU regulatory requirements for drug delivery systems Some ad hoc travel may be required with this role within Europe and the US. We offer a competitive salary and benefits package, and the opportunity to work flexibly. #IND #LI-RL1

Responsibilities

The main purpose of this role is to lead device development programs, ensuring they meet functional performance, manufacturability, and commercial requirements while adhering to regulatory standards within established timescales and costs. Key responsibilities include providing technical leadership for drug delivery device design from concept to commercialization, managing design control documentation, and overseeing the preparation and implementation of performance test plans.