Sr. Manufacturing Engineer
Hands-on, experienced manufacturing engineer with drive, ambition and desire to own and execute all aspects of, manufacturing engineering, production and product support/servicing to achieve world-class results. Responsible for manufacturing engineering and production of both durable and disposable products.
MAJOR DUTIES AND RESPONSIBILITIES
· Drive manufacturing engineering and work closely with R&D and Quality to effectively transition products to manufacturing. Key representative and contributor in project development team
· Define operations processes, including hands-on definition of MPIs, TPs, DHRs, etc
· Conduct PFMEA analyses. Define and execute process validations.
· Must be hands-on in executing day-to-day tasks as well as strategic, able to develop world-class operations.
· Select, qualify, and manage contract manufacturers. Hire, train, and supervise manufacturing staff.
· Define operations initiatives, apply analytical and statistical methods to continually improve quality, reduce cost, reduce cycle time and simplify processes.
· Ensure compliance with company policies, procedures, and regulatory.
· May lead or support failure investigations. Collaborates closely with cross-functional groups.
· Assist in facilities expansion & facilities maintenance.
· Collaborate cross-functionally to define product servicing strategy and infrastructure. Establish L1 (service desk) and L2 (break fix) support.
· Other tasks as requested by management
Education and/or Job Experience:
· A minimum of 10 years' experience in one or more disciplines of manufacturing operations (e.g., manufacturing, assembly & test, manufacturing engineering, subcontract, service)
· At least 1 year in a direct-line managerial position of teams that perform manufacturing, manufacturing engineering and/or operational execution functions
· Medical device experience required
· Must have a solid background in successfully managing CMs (onshore or offshore)
· Technical knowledge of assembly and test of electronic equipment
· Excellent knowledge of manufacturing engineering, ERP systems, quality assurance and lean manufacturing
· Must be flexible, detail oriented, and extremely organized, with a positive outlook, enthusiasm, and high energy; ability to thrive in a rapidly-growing, dynamic, drive-for-excellence environment
· Proven team leadership and excellent communication skills
· Demonstrated knowledge of FDA regulations, ISO 9001, ISO 13485, and other national and international regulations and standards
· Experience at both large companies and start-ups preferred
· Controlled environment room (CER) experience preferred
· Bachelor's degree in business management, engineering, manufacturing, industrial engineering, or a related discipline preferred
Special Skills, Abilities, and Requirements:
Proven leadership abilities. Excellent communication skills; written, verbal and presentation. Microsoft Office (Word, Excel, Project, PowerPoint, Visio) skills. SolidWorks, Adobe Acrobat Professional, Adobe Illustrator, Zebra Printer hardware/software