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Manufacturing Process Optimization Specialist
2 months ago
We are seeking a highly skilled Principal Process Engineer to join our team at fishRecruit Inc. as we continue to drive innovation in the medical device industry.
Key Responsibilities- Lead process development on cutting-edge NPI development projects, working collaboratively with cross-functional teams.
- Develop and implement new manufacturing and process technologies to support product development and product transfers.
- Apply new technologies and methodologies to optimize process design and performance.
- Establish processes based on product specifications in line with Unit Cost metrics.
- Evaluate process and design alternatives based on Design for Manufacturability principles.
- Apply principles of lean manufacturing, problem-solving, and DOE to drive process improvements.
- Complete process validation for new processes and products, including IQ, OQ, PQ, and PPQ.
- Work with external vendors to specify, develop, and commission new process technologies.
- Set up new manufacturing equipment/production lines, including the selection and training of process technicians and product builders.
- Develop manufacturing processes from prototyping to full-scale production.
- Initiate and complete technical activities leading to new or improved products or processes for current programs and next-generation programs.
- Identify process risk and drive mitigation strategies.
- Understand and ensure compliance with work environment issues, including H&S activities associated with new process development.
- Degree or equivalent in an engineering discipline, with 9+ years of experience in manufacturing process design and optimization within a highly regulated environment.
- Proven ability to conceptualize and deliver automated solutions as needed.
- Experience in using Six Sigma methodology for process improvement (e.g., DMAIC) and problem-solving.
- Advanced skills in statistical analysis and use of Minitab.
- Strong knowledge and ability to teach Design of Experiments.
- Demonstrated experience leading and mentoring technical teams.
- Excellent proficiency in SolidWorks.
- Exceptional oral and written communication skills for engaging with various organizational levels.
- Proficiency in two or more of the following processes: laser welding, reflow technologies, braiding, coiling, laser cutting, injection molding, hydrophilic coating, and adhesive bonding, all relevant to the manufacturing of medical devices such as catheters, sheaths, steerable catheters/sheaths, dilators, and guidewires.
- Strong mechanical background with a working knowledge of metals and plastics processing.
- Experience in training and mentoring engineers in problem-solving and process development tools.
- Working knowledge of relevant medical device regulations and guidance (e.g., ISO).
- Previous experience in a disposable medical device manufacturing environment.
- Expertise in the design of catheters, dilators, needles, and guidewires.
- Experience with braiding and reflow processes.
- Expertise in polymer/metal component design and manufacturing, including part design, injection molding, reflow, bonding/welding, heat treatments, and casting.
- Proficiency in fixture and tooling design.
- Experience with automated work cell and equipment design.
- Strong background in mechanical mechanism design and analysis.
We are a leading company in the medical device industry, dedicated to improving patient care through advanced medical device technology. Our team consists of intelligent and success-driven individuals with a strong inspiration to improve the lives of others.
We offer challenging and meaningful careers for individuals inspired to work in the biomedical industry. Our company culture is built on a foundation of innovation, collaboration, and a commitment to excellence.
We are committed to providing our employees with a comprehensive rewards package, including tuition reimbursement and a health spending account. We also offer abundant opportunities for on-site training, workshops, and personal development.
Join our team and be a part of a thriving workplace culture filled with employee-led clubs, campaigns, sports teams, and exhilarating activities – fostering camaraderie and fun.
