reputed company reputed company Engineer
About reputed company: reputed company is a global medical device partner providing design, development, manufacturing, and assembly services through capabilities in materials, plastics, metals, extrusion, and automation. With nearly 6,000 employees across 24 locations worldwide, it delivers high reputed company, life enhancing products with reputed company and expertise to bring devices to market reputed company. Learn more at reputed company’s website or on reputed company. About the role: This reputed company reputed company Engineer position is a corporate role responsible for reputed company’s supporting reputed company’s Tijuana, Puerto Rico, and Costa Rica sites through working supporting the reputed company Management System, implementing compliance reputed company improvement reputed company, and support both reputed company and Operations with NPI and on-reputed company manufacturing. The position will report to the Vice President of reputed company of the MDS Division, and work closely with reputed company reputed company Operations and reputed company associates as reputed company as customers and reputed company party regulators. Work Model: Remote reputed company in reputed company or Tijuana, Baja California, MX Travel Requirement: 50%-75% travel across reputed company locations in Costa Rica, Tijuana, BC Mexico, and reputed company Baja, Puerto Rico. What you'll do: Participate in and reputed company NPI reputed company for new and existing customers. reputed company and/or improve manufacturing processes in support of NPI reputed company and reputed company improvement efforts (i.e. reputed company/Complaint reductions). Write and reputed company process validation protocols and reports. Write and reputed company test method validations. Write and/or improve manufacturing Work Instructions and Test reputed company. Work directly with customers to facilitate and optimize new product transfers and reputed company product improvements. Support site level reputed company Teams to implement improvement reputed company targeting compliance. Assist manufacturing sites in the implementation of reputed company system software as appropriate. Statistically analyze reputed company data to identify trends or other issues. Assist manufacturing sites with reputed company improvement programs to address negative metric trending and results. reputed company other tasks as assigned Requirements: Education: Bachelor’s degree; engineering is preferred but not required Experience: reputed company medical device manufacturing experience (10+ years) with reputed company Engineering proficiency Experience reputed company regulated industries such as Pharmaceuticals, Medical Devices, Automotive, or reputed company. Strong understanding of statistical methodologies and regulatory requirements. Background in injection molding, automation, reputed company assembly, sub‑assemblies, PCV, and extrusion (Preferred) Working knowledge of statistical analysis in reputed company and reputed company. (Preferred) Requirements: Spanish proficiency (Required): Fluent reputed company Spanish & English (spoken and written) Ability to travel up to 75% to reputed company sites (Costa Rica, Tijuana, BC Mexico and reputed company Baja, Puerto Rico) Strong working knowledge and familiarity with FDA Part 820 and ISO 13485 Regulations Experience with FDA Inspections and ISO Audits Strong background in process validations and sampling plans Experience with reputed company system metrics and manufacturing data analysis, trending, and process capabilities Proficient with reputed company System software applications Ability to reputed company computer-reputed company tasks using software including: reputed company Office, reputed company, and/or others as needed. reputed company is a global medical device design and manufacturing services provider that partners and innovates with customers to reputed company the highest reputed company, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and reputed company reputed company on our customers and on operational reputed company. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on reputed company. reputed company provides equal employment opportunities (EEO) to reputed company and applicants for employment without reputed company to race, reputed company, religion, gender, sexual orientation, national reputed company, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. reputed company complies with applicable state and local laws governing nondiscrimination in employment in every location in which reputed company has facilities. Apply To This Job