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Senior Product Development Engineer
- Holds a professional scientific qualification
- Experienced within Medical Devices / Healthcare / Pharmaceutical
About Our Client
Global FMCG Manufacturer
You may be involved in the following activities as part of your day to day responsibilities:
- Establishment of user needs and generation of key design inputs would be a key part of this role.
- Ensuring compliance of design control and design change activities through the review and acceptance of design activities independently of the NPD design team.
- Ensuring that Design History Files and other associated quality documentation are complete and compliant by means of review and approval.
- Working with NPD teams you will be able to generate the relevant verification and validation output that meet design inputs through the creation-review-execution of test cases and participation in product risk analyses and change reviews.
- Taking a lead role in the adaptations of test methods, equipment acquisition for product testing, validations/qualifications, statistical analysis of data for significance and other requirements through review and approval of protocols and reports.
- Participating in the creation and approval of complete, unambiguous, and measurable design outputs.
- Reviewing and approving specifications, including those for raw materials, intermediate products and finished products.
- Maintaining currency of knowledge required to carry out the essential duties and responsibilities effectively.
- Performing all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
- Applying high standards of occupational Health & Safety in the workplace to comply with company policy and procedures.
- Providing support to Operations and Downstream QA teams to ensure successful transfer of the design and design controls to manufacturing, in accordance with all applicable regulations.
The Successful Applicant
- Holds a professional scientific qualification e.g. B.Sc. Hons Electro-Mechanical / Electrical/ Manufacturing Engineering or equivalent science or chemistry based degree with a 2:2 classification minimum result.
- Or a HNC or equivalent qualification with at least relevant experience in a similar Quality, Compliance or Regulatory related role in relation to product development within a Medical Devices and / or Medicinal Product / Healthcare / Pharmaceutical environment.
Experience, Attributes and Knowledge:
- Experience of leading the design of medical devices would be a requirement to be successful in this role.
- Project Manager Leadership experience would be key alongside the ability to mentor other members of the wider team who may need support and training.
- Position requires the individual to demonstrate a good understanding of QA and have substantial relevant experience within this type of area to be able to lead aspects of this project.
- The jobholder will act as a team player in the organization by being aware of the scope, responsibility and authority of his/her functions and activities and their impact on product and service quality as they relate to applicable laws, regulations and standards.
- The role is pivotal in ensuring that scientific and analytical information is provided to support quality, product safety, design control, marketing support activities and the quality/shelf life of products in order to ensure that the projects are successful.
- The role serves as an example of quality excellence, applies technical rigour in problem solving and analysis, mentors and teaches less experienced quality staff and maintains currency of all necessary legislation, regulation and standards.
- Successful individual will be able to work independently and be comfortable not being micro-management but also work collaboratively across different areas.
What's on Offer
Competitive salary and benefits - 12 month Fixed Term Contract