Senior Manufacturing Engineer
2 weeks ago
Position Overview:
About Cretex Medical Component and Device Technologies
Cretex Medical Component and Device Technologies is a premier contract manufacturer specializing in precision components and assemblies tailored for the medical device sector. Our clients regard us as a reliable collaborator in the domains of injection molding, laser processing, metal stamping, and device assembly.
Senior Manufacturing Engineer Position Summary
The Senior Manufacturing Engineer is tasked with spearheading the development of manufacturing processes for new products and the integration of innovative manufacturing techniques. This role encompasses the planning, design, development, and maintenance of programs, training, and manufacturing processes, including machining, packaging, welding, assembly, and molding.
Key Responsibilities:
- Collaborate with the new product development team at Cretex Medical, focusing on initiatives that introduce advanced technology and manufacturing solutions.
- Devise manufacturing strategies for new projects, whether driven by customer needs or internal objectives.
- Engage with both external and internal project stakeholders, ensuring timely updates regarding project status, schedules, risks, and potential delays.
- Oversee the process flow and execution of all necessary procedures for assigned projects or products.
- Facilitate the adoption of new technologies at Cretex Medical, which may involve vendor selection, equipment procurement, installation qualification/system assurance, process development, and training.
- Compose technical reports summarizing production builds and maintain relevant work instructions.
- Utilize engineering principles to analyze and resolve a spectrum of challenges, from fundamental concepts to complex issues requiring innovative solutions.
- Collaborate with quality assurance and manufacturing teams to seamlessly integrate new products or processes into existing production workflows.
- Manage and validate device routers and bills of materials.
- Review and endorse manufacturing procedures.
- Design and coordinate the fabrication and implementation of process fixtures or gauges.
- Evaluate and map processes, assess efficiency, and execute intricate project activities.
- Assist in estimating part costs.
- Mentor junior engineers.
- Adhere to and support the company’s Quality System, ISO standards, and medical device regulations.
Qualifications:
- Bachelor's Degree in Mechanical, Industrial, or a related Engineering discipline.
- A minimum of 5 years of engineering experience in a manufacturing environment, including exposure to cutting-edge manufacturing technologies and cost reduction strategies.
- Experience in an ISO13485/GMP setting.
- Engineering background in medical device manufacturing.
- Proficiency in manufacturing process design and validation.
- Experience in designing manufacturing equipment and fixtures/gauges.
- Familiarity with lean manufacturing principles.
- Strong team dynamics skills, including communication, accountability, decision-making, feedback, meeting management, and conflict resolution.
- Knowledge of design of experiments (DOE), statistical process control (SPC), failure mode and effects analysis (FMEA), good manufacturing practices (GMP), and quality system regulations (QSR).
- Proficient in statistical software.
- Understanding of materials and associated processes.
- Project management experience.
- Experience with manufacturing automation, including electronic visual inspection.
- Proficient in 3D CAD software (e.g., ProE, Unigraphics, Solidworks).
- Exceptional communication and influencing abilities.
- High energy level, personal accountability, and integrity.
- Detail-oriented with a strong emphasis on accuracy and organization.
- Able to manage ambiguity, multiple priorities, and tight deadlines.
Preferred Knowledge, Skills, and Abilities:
- Commitment to ongoing education, including participation in local chapters, associations, and/or organizations.
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