Sr. Manufacturing Engineer

Location
Hayward, California
Posted
Oct 23, 2017
Required Education
Bachelors Degree
Position Type
Full time

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