Sr. Manager/Director Instrument Manufacturing Microchip Biotechnologies
THIS JOB HAS EXPIRED Date Required: Immediately
Position: Permanent fulltime
Bachelor?s degree in Mechanical, Electrical, or Manufacturing Engineering or Equivalent. Advanced degree highly desirable.
? Minimum 10 years of Manufacturing Engineering experience in life science or molecular diagnostics instrumentation
? Minimum 5 years working in an ISO 9001, ISO 13485 environments
? Minimum 4 years experience with Solid Works 3D solid modeling software
? Ability to analyze components and assemblies for static and fatigue strength to meet design goals
? Ability to correctly utilize standard test and measurement equipment to quantify design margins and problems.
? Complete understanding of the PDP cycle, phases and requirements. Proven track record of product release following a PDP process
? Experience in presenting technical materials in written and verbal form
? Released at minimum two successful instruments to contract manufacturing in the USA or abroad
? Direct technical accountability for Internal and Contract Instrument Manufacturing.
? Leads the selection process for instrument Contract Manufacturers by:
1. Evaluating the technical capabilities of the Contract Manufacturer to ensure they are consistent with needs of the instrument design, working with R&D as needed
2. Evaluating the logistics and supply chain capabilities of the instrument Contract Manufacturer
3. Evaluating the Quality Systems capabilities, working with Quality as needed
4. Evaluating the cost effectiveness of the Contract Manufacturer working, with finance as needed
? Manages the on-going technical relationship with the Contract Manufacturer to ensure their performance. Develops alternatives to existing Contract Manufacturers and continually re-evaluates strategy to ensure best overall value per unit cost over time and to minimize risk.
? Direct technical responsibility for the New Product Introduction as well as the technology transfer to Contract Manufacturers. Provides direction and acts a primary technical and logistical conduit between IntegenX and Contract Manufacturers. Works actively with the Contract Manufacturer suppliers for COG?s reduction, quality improvements, minimization of inventory exposure and Design for Manufacturability.
? Manages creation and improvement of products/projects that involve Instrument Engineering/ Manufacturing
? Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of hands-on tasks. Will direct the work of the instrument manufacturing engineering team.
? Accountable for overall management of Instrument Contract Manufacturer relationships
? Accountable for the Instrument manufacturing engineering organization
? Primary technical interface between IntegenX and Instrument contract manufacturers
? Primary driver / representative for Instrument New Product Introduction
? Instrumentation interface to R&D during the feasibility, development and transfer to commercial phases of the PDP
? Interacts regularly with engineers/scientists and other development personnel to determine project requirements, goals, schedules and cost targets
? Working with R&D will drive the design for Manufacturability, starting in feasibility through release to contract manufacturing
? Analyzes and solves complex problems using creative and effective techniques or processes.
? Develops new documents for SOPs, WI, and training of assemblers for instruments
? Frequent intra-and inter-organizational and external customer contacts
? Provides direction in determining objectives of assignments
? Independently plans work and determines and develops approach to solutions.
? Provides technical guidance as necessary
? Participates on product or project core teams as required
? Maintains and enhances technical knowledge on company product lines through attendance and participation at in-house training programs, as well as self-study by reading trade journals, manuals and books
? Assists in the training of manufacturing personnel on subassemblies and final assembly builds
? Assists in defining the raw material definitions and specifications
? Assists in the qualification of suppliers
? Proficient in complex project management spanning multiple organizations to build complex life science instrumentation
? Ability to apply engineering principles using logical or scientific thinking to define problems, collect data, establish facts, and draw valid conclusions
? Well versed in current ?global best practices? for instrument manufacturing and uses this knowledge to continually evolve the company?s instrument manufacturing strategy and practices consistent with the company?s size and resources as it evolves and grows
? Ability to critically evaluate a Contract Manager?s capabilities and drive the initial selection and ongoing evaluation process
? Ability to effectively manage the Contract Manufacturer and develop effective alternatives as needed
? Competency with SolidWorks 3D solid modeling software. Understanding of the principles of SolidWorks file management. Demonstrates expertise in aspects of solid modeling (e.g. sheet metal, surface modeling, assembly modeling, etc.)
? Understanding of the use of PLM, ERP, PDM works to store, retrieve and manage the revision levels of engineering documentation and project planning materials
? Fluent use of MS Office suite (Word, Excel, Power Point, Project). Familiarity with other software such as Visio, etc.
? Strong written and verbal English communication skills
? Competency with SolidWorks 3D solid modeling
? Competency with PLM and ERP systems
? Excellent knowledge of supply chains as they relate to instrument manufacturing
? Expert knowledge of Manufacturing Engineering of mechanical and electrical assemblies
? Must have knowledge to design manufacturing tools used in the manufacturing and assembly of instruments as well as instrument subassemblies
? Must have knowledge to define requirements and specification necessary for sub-system modules and complete instrument test routines required for system validation
? Technical knowledge of molecular and biochemistry
? Collaborative team player a must
? Core teams
? Customer Service
? Technical Support
? Field Applications
Additional Job Abilities:
? Requires the ability to perform independently and as part of a team
? Ability to communicate in a clear, concise, personable manner
? Ability to teach and present in one-on-one or group situations
? Experience with the design and manufacturing of plastic injected/RIM molded parts and aluminum molds
? Experience with laser based systems
? Ability to develop test programs using Lab View
Working Environment/Minimum Physical Requirements
? Appropriate safety precautions are required in designated areas, laboratories, and customer sites
? Job duties are performed in laboratories and offices.
? Travel to contract manufacturer required (sometimes daily)
||Pleasanton, CA |
THIS JOB HAS EXPIRED