Position Overview:
The Manufacturing Engineer II plans and designs manufacturing processes for a production facility. Maximizes efficiency by analyzing layout of equipment, workflow, assembly methods, and work force utilization. Being a Manufacturing Engineer II determines the parts, equipment, and tools needed to achieve manufacturing goals according to product specifications.
Responsibilities:
• Evaluate current catheter manufacturing practices and identify those needing improvement.
• Lead operations to increase production capacity and implement new efficient processes.
• Analyze and design sequence of operations and workflow to improve efficiencies and establish methods for maximum utilization of production facilities and personnel.
• Use Lean Manufacturing Methodology, including Value Stream Mapping and Kaizen events.
• Use Six Sigma Methodology (DMAIC or DMADV) and tools including Minitab, FMEA, Fishbone, Process Mapping, etc.
• Responsible for manufacturing process development, implementation, and continuous improvement to enhance yield, reduce cost and improve productivity.
• Represent Process Engineering in assigned R&D and Project Team meetings for technology transfers and provide technical expertise and support in analytical method development, validation and process scale, and current production capabilities in manufacturing.
• Performs or manages process validations (IQ, OQ, PQ).
• Troubleshoot production line issues related to yield, quality, and throughput.
• Leads scaling up processes from development to full scale manufacturing.
• Supports evaluation of NCR, CAPA, SCAR, Failure investigation and Deviation requests arising from Contract Manufacturers/Suppliers.
• Creates/Updates manufacturing instructions, routings, bills of materials and SOPs.
Qualifications:
Education:
• Engineering degree desired or equivalent experience in related job field.
Required Experience:
• 2+ yrs Biomedical product or medical device development experience.
• Working knowledge of mechanical design principles and FDA regulated medical device design controls a plus.
• Proficient in CAD software, preferably SolidWorks.
• Familiarity with statistical analysis of raw data is required, proficiency in Minitab is preferred.
• Hands-on experience managing suppliers and/or contract manufacturers a plus.
• Familiarity with design control according to 21 CFR 820 or ISO 13485, engineering change orders (ECO), Corrective Actions and Preventive Actions (CAPA) preferred.
Knowledge, Skills, and Abilities:
• Knowledge of ASME Y14.5 GD&T.
• Excellent interpersonal, communication, and documentation skills are required.
• Takes initiative and acts quickly to drive solutions.
• Strong interpersonal, organizational and communication skills.
• A flexible team player, focusing on shared goals with a positive results‐oriented attitude.
...We are looking for a Customer Service Manager to join our team! The Customer Service Manager - Americas leads the customer service team and ensures service levels are met or exceeded, while achieving agreed team targets (departmental targets), and harmonization of external...
...Designer Role **Must take PPT/MS Office Assessment if shortlisted 1st Shift: 7am to 3:30 pm ( hour unpaid lunch) Live Deal projects... ...expert o Photoshop expert o Strong Excel o Heavy graphic design role. Hybrid position with half workflow and half design...
...meetings as required MENTAL HEALTH CLINICIAN ( LCSW, LPCMH, PsyD) MINIMUM REQUIREMENTS: Must have a graduate degree in psychology, social work, counseling, or a related field. MUST be licensed (i.e., LCSW, LPCMH, PsyD). - LMSW does not count as a clinical license....
...performance. Education: ~ BS in Medical Technology preferred; or BS/BA in Chemistry or Biology, or Associates degree in a Laboratory Science or Medical Technology, or Previously qualified as a Technologist under 42 CFR 493. ~1433 published in March 14, 1990. ~ Foreign...
...ensuring seamless operations and effective collaboration. Key Responsibilities: Attend meetings with mass retailers and suppliers (virtual and in-person) alongside the Executive Account Manager to take detailed notes and assist with follow-up tasks. Assist in...