Process Development Engineer
2 months ago
Confluent Medical Technologies is a thriving medical device company dedicated to providing life-saving solutions through a collaborative and impactful work environment. Our diverse range of technologies and material science capabilities empower our employees to develop broad skill sets and directly influence product development and manufacturing outcomes.
We are seeking a highly motivated Process Development Engineer - Medical Textiles to join our talented team.
Position SummaryAs a Process Development Engineer, you will play a crucial role in developing innovative medical textile-based structures to meet customer needs. Your responsibilities will encompass guiding products through development, validation, and ultimately into production.
Duties and Responsibilities- Lead technical teams on development programs, collaborating closely with project managers, engineers, operations, and quality personnel under the guidance of the Textile Development Engineering Manager.
- Spearhead process development, characterization, optimization, validations (including IQ/OQ/PQ), and seamless transfer to production environments.
- Engage in hands-on work on the shop floor while developing processes and training aids.
- Design, execute, and present comprehensive reports on various engineering studies such as Design of Experiments (DOE) and Coefficient of Variation (COV).
- Author and review essential procedures, work instructions, and Standard Operating Procedures (SOPs).
- Collaborate with teams to identify product/process risks and implement strategies to mitigate them. Provide technical input for Quality deliverables such as Process Failure Mode and Effects Analysis (pFMEAs).
- Interact directly with customers to understand their product and validation requirements, offering tailored solutions and strategies.
- Build relationships with external vendors, suppliers, and consultants.
- Bachelor's or Master's degree in Mechanical Engineering, Textile Engineering, Biomedical Engineering, or a related field.
- Minimum of 5-10 years of experience in a manufacturing environment.
- Proven ability to provide technical leadership and hands-on expertise to teams.
- Exceptional ability to manage multiple projects and tasks simultaneously.
- A passion for innovation and problem-solving skills.
- Industry experience in medical, textile, aerospace, or automotive sectors.
- In-depth knowledge of various textile products and processes, including braiding, knitting, weaving, and non-woven techniques.
- Six Sigma Green or Black Belt certification.
- Lean manufacturing experience and knowledge.
- Proficiency in software such as Solidworks, AutoCAD, Creo, and Minitab.
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