Mantell Associates is partnered with a commercial-stage Medical Technology firm, who are searching for a Senior Sustaining Engineer to join their growing team.
Senior Sustaining Engineer - Responsibilities:
- Manage engineering activities required to support products through the commercialized life cycle
- Provide engineering support for design and/or process changes of existing products including ownership of change control documentation to support project execution
- Provide recommendations and implement solutions for highly complex problems which reflect an understanding of business objectives and cost implications
- Design and develop manufacturing processes, tooling and fixtures to meet business needs while enhancing process quality, productivity and safety
- Provide engineering support for equipment qualifications and process verification and validation studies including protocol development, execution, data analysis and writing final reports
- Ensure appropriate process documentation and validation to lead manufacturing transfer and scale-up
- Develop/update work instructions, workmanship standards and process documents as needed and provide the required training for technicians and operators
- Monitor and assess the performance of manufacturing processes and work with R&D and Quality to promptly address any emerging issues and implement solutions
- Provide engineering support for non-conforming products, customer complaints, product returns and CAPA’s including leading root cause investigations and implementing short term and/or long term corrective actions to prevent recurrence and reduce business risk
- Support continuous improvement of existing manufacturing operations for increased quality, productivity, workflow, reliability, efficiency and cost savings
- Support sourcing and approval of suppliers for manufacturing processes and equipment
- Provide support to resolve supply chain issues, component obsolescence issues and identification of alternate suppliers including interface with suppliers/customers as needed
- Provide support for regulatory approvals and responses to regulatory questions for existing products
- Proactively communicate project progress, risks and recommendations to management as appropriate
- Perform other tasks and duties as required to contribute to the overall success of the team and organization
Senior Sustaining Engineer - Requirements:
- Bachelor’s degree in Mechanical or Biomedical Engineering (or related Engineering degree)
- 5-8 years of hands-on experience in medical device development, production or regulated industry
- Experience with ISO 13485 and FDA Quality System Regulations
- Experience with Minitab or other statistical evaluation software
- Lean Six Sigma training or certification and knowledge of statistical data analysis techniques (DOE, GR&R, Cpk, SPC)
- Risk management experience (DFMEA, PFMEA)
- CAD experience (preferably SolidWorks)
- Demonstrated project management skills with ability to prioritize multiple concurrent projects in a fast-paced environment and identify/resolve issues as they arise with minimal supervision
- Cross functional team player with a strong work ethic, strong engineering and problem solving skills, creative thinking, good decision making skills, high attention to detail, effective interpersonal skills and excellent verbal/written communication skills
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.
