Stop the press!! Product Development Engineers with systems or mechanical design engineering experience, who enjoy working across the full product lifecycle, I need to speak with you about this opportunity.
The Product Development Engineer role is perfect for an innovative, hands-on self-starter who would like to work as part of a driven and supportive team which designs and manufactures novel medical device products to improve the world around us!
The role would ideally suit a systems or mechanical design engineer, who enjoys working across the full product lifecycle - from product concept through to manufacturing support. The role will include support and maintenance of existing products and will require proficiency in the use of Solidworks for CAD updates to systems or components.
The role is ideally suitable for an experienced engineer with a background in medical device development. However, candidates with experience in different regulated industry sectors or excellent graduates with a focus upon medical devices or systems engineering will also be considered and training provided.
As a medical devices company, certified to ISO 13485, accuracy of documentation is essential throughout the organisation. The ideal candidate will have acute attention to detail, with a rigorous and methodical approach to defining task requirements and ensuring deliverables are comprehensively met.
Your deliverables will include the following:
Product Development
Design, Development and qualification of new medical device products in accordance with the Company's design control procedures and quality standards (including ISO 13485 and QSR).
Defining and carrying out verification and validation activities to agreed schedules, quality and cost.
Employing best practice design and development techniques including (where applicable) simulation, design for manufacture, design for test, reliability analysis and single fault analysis.
Planning, defining and development of equipment and jigs to support verification and production.
Working with and managing suppliers, subcontractors and other engineering disciplines.
Requirements management activities.
Creation of Customer Facing documentation including instructions for Use and User Manual Documents.
Supporting the existing product range through upgrades resulting from regulatory changes or customer requests, in accordance with change control procedures.
Quality Assurance
Completion of Non-Conforming Product (NCPs) or Corrective and Preventative Action investigations (CAPAs) as required by the Company's quality standards.
Providing technical support for customer returns or complaints.
Providing technical support for QA investigations.
Operations
Supporting Operations through management of product Transfer To Manufacturing; project handover.
Definition and generation of manufacturing documentation (e.g. assembly and test procedures) in compliance with quality standards.
Supporting the implementation of best practice manufacturing techniques for one-off designs to high volume production, assembly processes and material selection.
Ongoing technical support for manufacturing where required including debug activities and process improvements.
Marketing / Research
Supporting Marketing & Research through technical contribution to feasibility analysis and bid development on proposed new projects or product developments.
Supporting Marketing documentation preparation through generation of product renders or required technical data.
What you’ll need to succeed
You will be an energetic, passionate, self-starter with a positive disposition and someone who will relish a working environment which is focussed on growth and the changes needed to deliver it.
Some of the key skills you’ll bring are:
- Bachelor's degree in Mechanical or Electronics Engineering (or similar).
- Minimum of 2 years' experience in product or systems development, primarily Mechanical design focused.
- Proficient with 3D modelling software and technical drawing, Solidworks preferred.
- Practical hands-on approach. Basic electronics experience would be beneficial e.g. multimeter measurements.
- High standard of communication and written skills.
- Working knowledge of product change management (Engineering change orders).
- Confidence in creation of specifications, test plans and reports.
- Familiarity with process risk management, e.g. FMEAs. Knowledge of product risk management to ISO 14971 would be beneficial.
- Teamwork skills and ability to create ideas and develop solutions.
- Experience in interfacing with manufacturing facilities, suppliers or design subcontractors would be beneficial.
- Knowledge of medical devices standards, particularly ISO 13485 and IEC 60601 is desirable but not essential as training will be provided.
- Experience of working within the medical devices sector or a similar highly regulated sector is not essential but would be advantageous.
- Driving license and ability for infrequent travel, primarily to local CEM partner.
What you’ll get in return
· Salary: TBC.
· Pension: 3% Employers contribution.
· Annual Leave Allowance: 33 days (including bank holidays)
· Bright, modern work environment with a focus upon employee wellness. A planned move during 2023 to a custom designed facility in Stirling, with excellent commuting links and which includes an employee gym and wellness suite.
- Agency: Cpl Life Sciences
- Reference: JO-2302-510926
Website: Cpl Life Sciences
- Posted: 21st February 2023
- Expires: 21st March 2023
