Design Assurance Engineer

Arrotek Medical is a medical device engineering company offering a range of development and
manufacturing services from initial design assessment, through to the provision of sterile finished
product for the European and US medical device market. We strive to provide employees the
opportunity to work in a competitive, growing and dynamic environment, for career development
and employee wellness through providing a competitive employee package. For further information
on Arrotek Medical, visit https://www.arrotek.com
https://www.linkedin.com/company/arrotek-medical-ltd/.

We are currently recruiting for the position of Design Assurance Engineer.

Responsibilities

The responsibilities for this position will include the following:

  • Assist with the development of quality evaluation and control plans and protocols for
    processing materials into finished products;
  • Issue of Product paperwork/lot records to manufacture and also review and release of same
    and compile COA/COC;
  • Support QMS as Quality Coordinator in the investigation into non-conformances,
    participate in root cause analysis and with disposition and or agree corrective and
    preventative action (CAPA) recommendations related to manufactured products including
    review and approval of deviations and customer complaints etc.;
  • Performing an active role in further development and continuous improvement of the QMS;
  • Quality review of cGMP documentation, SOP’s, WI’s, templates etc. to ensure compliance to all applicable regulatory standards and cGMP procedures and practices;
  • Quality review of responsible area validation documentation of Design & Development Documents;
  • Liaise with suppliers and customers on quality related issues;
  • Participating in design reviews and the compilation of associated documentation;
  • Co-ordination of internal testing reports, biocompatibility testing reports & technical file development, sterilization qualification;
  • Generate & Maintenance of Product Design Files;
  • Support/Ensure Regulatory compliance in projects of responsibility by utilising quality tools and processes (Risk Management, Risk reduction, process change analysis);
  • Routinely provides design assurance guidance & direction to project manager & design engineers for the duration of a project development;
  • Work closely with product development engineering team and the client to establish design specifications and product requirements;
  • Support execution of Design Verification and Validation planning;
  • Ensure DHF content completion, and regulatory & standards compliance; collaboratively communicating & resolving gaps;
  • Assist Head of Quality in implementing and maintaining the QMS;
  • Conduct internal audits, including closing out audits in a timely manner, creating audits finding reports and determine proper corrective and preventive actions;
  • Support and assist in the preparation for customer and surveillance accredited audits;
  • Drive continuous improvement and best practices in QMS “Right First Time”;
  • Maintains safe and healthy work environment by following standards and procedures, complying with legal regulations;
  • Updates job knowledge by participating in educational opportunities;
  • Other such duties as may be assigned from time to time by their Manager.

The above statements reflect the general tasks, duties, activities and/or responsibilities necessary to describe this position and is not intended to set forth all of the specific requirements of the job. These job duties/responsibilities may change or vary in response to business needs.

Person Specification:

Candidates likely to be called for interview will have most or all of the following:

Qualifications and Education Requirements:

  • Minimum Degree in a Science or Engineering discipline.
  • 3-5 Years’ experience working in a medical device environment in a Design Assurance
  • Engineering role, (preferably with involvement in product design and R&D).
  • Strong knowledge of ISO 13485, FDA regulations 21CFR 820.
  • Internal/external auditing experience would be an advantage.
  • Validation experience including Sterilization, process and packaging validations would be
    beneficial.
  • Knowledge of Medical Device manufacturing environment including cGMP would be an advantage.
  • Understand general principles of ISO 14971.

Preferred Skills

  • Decision making ability coupled with the ability to work on own initiative and with minimum supervision is required, and ability to multitask and prioritise.
  • Demonstrate detailed working knowledge of the medical device industry.
  • Must have good written & oral communication skills and the ability to communicate appropriately with different engineering teams, Project Management, suppliers and customers.
  • Desire to learn new tasks and flexibility.
  • Attention to detail while maintaining awareness of longer-term objectives.
  • Capacity to maintain the highest level of confidentiality internally and externally.
  • Have MS Office Experience (Word, Excel, PowerPoint etc.).
  • High level of teamwork and engagement, while at the same time being able to work on their own initiative/ Excellent communication skills, both written and verbal, maintaining confidentiality at all times/ Excellent attention to detail, with strong numerical and problem-solving ability.

Position Details

• Permanent Contract
• Start Date; ASAP
• Full time

Applications:

Interested applicants should submit their up to date CV and Cover Letter to recruitment@arrotek.com. All applications will be treated in strict confidence.

Arrotek Medical is an equal opportunities employer.

Our Medical Device Design Work