Mechanical Product Support Engineer
To provide design engineering input to ensure that changes required to released products to meet on-going business needs are conducted on time, within budget and with the required level of quality, whilst acting as mentor to engineers within team and project leader on smaller projects.
- Provide design and development support to products post launch, coordinating design and manufacturing changes and improvements to meet defined device and manufacturing requirements.
- Accept the introduction of new products and ensure their efficient on-going transition into regular production by appropriate provision of a design authority service to operations and quality.
- Assessment of Non Conformance Reports (NCRs) and implementation of agreed corrective / preventative actions to maintain regulatory compliance.
- Maintain a strong and current understanding of relevant new product development and manufacturing technologies and their application to medical device design to meet or exceed customer, company and project needs.
- Evaluate and document the feasibility, reliability and risk to of changes to product designs and manufacturing processes through engineering design, analysis & testing to demonstrate the product performance, manufacturability, material selection, safety and cost are consistent with the customer and regulatory requirements.
- Develop timelines and cost estimate for development tasks and appraise management of performance against plan to maintain compliance to project schedule.
- Generate and review design history file documentation in compliance with Good Manufacturing Practice (GMP), Quality System Regulations (QSR), International Standards Organisation (ISO) and company Product Development Process (PDP) requirements throughout the project life cycle to ensure the design is fully documented.
- To be responsible for customer contact with respect to company products to ensure maintenance of product line and communication and buy in of design change implementation where required.
People development: Ensure engineers are developed within team to ensure core competencies are enhanced providing technical guidance, support and mentoring of engineers within the team
MINIMUM KNOWLEDGE, SKILLS & EXPERIENCE
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education / Qualifications:
- Bachelor’s degree in an appropriate Engineering discipline or equivalent with a minimum of 2 years' experience in a regulated and highly mechanical engineering design environment
- HNC/D in an appropriate Engineering discipline with a minimum of 10 years' experience in a regulated and highly mechanical engineering design environment
Behaviours / Skills / Experience:
- Ideally cGMP, ISO 13485, and FDA QSR knowledge as practiced in the disposable medical device industry
- Competent in MS Word, PowerPoint and Excel. Ideally medical device design or development experience
- Good analytical and mathematical skills.
- Understanding of a wide range of engineering technologies used in design and manufacturing
- Knowledge of mechanical design relating particularly to mechanisms
- Excellent knowledge of and ability to critique 2D engineering drawings and 3D modelling
- Good planning, organisation and control skills
- Able to use initiative
- Strong problem solving skills
- Excellent verbal and written communication skills
This job was originally posted as www.jobsite.co.uk/job/960538391