Job Title:
Principal Process Development Engineer
Job Summary:
We are seeking a highly experienced Principal Process Development Engineer to lead our Process Development and Manufacturing Engineering activities. The successful candidate will be responsible for ensuring the successful completion of projects, coordination of activities to meet company goals, and compliance with applicable standards and regulations.
Key Responsibilities:
* Lead technical leadership of manufacturing transfer of New Products and changes to existing products using Design for Manufacturability concepts.
* Develop and implement manufacturing capabilities using LEAN principles and tools.
* Work with Quality including management of NCMRs and CAPAs, Supplier monitoring and Audits, Risk management and internal controls.
* Contribute to the successful execution of departmental and company goals.
* Provide technical leadership for commercial manufacturing timelines, financial modeling, and technology transfer to partner or contract manufacturing organizations.
Requirements:
* Bachelor's Degree in Engineering or related specialty with a minimum of 7 years experience.
* At least 3 years in a Technical leadership role in a Biotechnology, Pharmaceutical, or Medical Device industry.
* Experienced in working within ISO 13485/FDA regulated quality systems with understanding and application of risk management methodology.
* Proven track record in manufacturing and process development in a regulated environment.
* Medical Device Catheter product experience a plus.
Desirable Skills:
* Knowledge and skills in DFM, Technology Evaluation, driving innovative solutions to complex problems, Process Design and Development, materials (Polymers and Metals), Design for Six Sigma principles, CAD, statistical techniques, process validation and control, and Manufacturing KPIs.
* Excellent analytical and decision-making skills, flexible approach to problem solving, adept negotiator, and risk-based decisions.
* Strong organizational, communication, interpersonal, managerial, and leadership skills.
About Us:
We are Career Wise Recruitment, established in 1999, specialising in recruitment of management and technical professionals for the life sciences, ICT, engineering, food, and agri sectors.