Description:

　　Working with daily non conformant and providing disposition. Working with vendors to develop rework instructions. Set up lower level documentation with some of the contract companies they use in Agile and Oracle, Creating part numbers and Bill of Materials. They contracted a bunch of products and they have the need to set them up in their system. Develop documentation and evaluate improvements. Non conformant that failed incoming inspections or the dimension is out of tolerance , cleaning is a big deal b/c it is an implant and documenting them in the system. Knowing when to ask is important. Developing work instructions and interfacing with suppliers, QA and supply chain. A lot of things they make they source from other suppliers so for example they had 3D printer parts that was missing a laser mark. How do we rework that and document it in our system? They are finished with the line duplication at their CA facility (fixtures built) and now they need to work on process and work instructions. They are setting up a machinery network inside their new facility that is attached to a Ethernet. Interface with IT and understand concerns related to the system.

　　Formal job description:

　　Develop, document, evaluate, monitor and improve manufacturing processes.

　　Work with the Design Team to ensure manufacturability and effective transition of new products to commercialization.

　　Prepare and present return on investment proposals (ROI) for management review, regarding anticipated capital equipment purchases, process improvements, quality improvements.

　　Responsible for selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture.

　　Define tooling and equipment maintenance activities and intervals.

　　Create project schedules and provide budgetary input for cost reduction and new product projects. Documents project activities.

　　Participate in the selection and qualification of new suppliers. Works closely with suppliers, purchasing and development to ensure design requirements are adequately defined and met.

　　Ensure new product manufacturability by conducting research, feasibility testing, and process validation.

　　Conduct and document verification/validation/engineering testing.

　　Conduct time studies to determine accurate labor standards for products supported.

　　Set up workflow routers and bill of materials in ORACLE/AGILE database.

　　Track and document actual vs. labor standards.

　　Generate and implement Engineering Change Orders.

　　Support production by developing shop aides/fixtures, manufacturing procedures, drawings & specification interpretation.

　　Provide progress reports to management as required.

　　Monitor and provide periodic reports on component product quality and take appropriate action to reduce costs due to defects.

　　Lead cross functional teams for the purpose of post market and continuous improvement activities.

　　Regular attendance required.

　　Skills:

　　non conformant, NCR, manufacturing engineering, process engineering, manufacturing process, cad, work instruction, change order, agile, oracle, process improvement, medical device, pharmaceutical, rework, manufacturing operations, process documentation

　　Additional Skills & Qualifications:

　　Good communication and interaction is critical. Implantable preferred. GMP. Support activities like IQ/PQ/OQ. Dealing with Rework and documentation them without impacting the quality of their products. Replacement for Brian Epstein

　　From the company job description:

　　Bachelors Degree, preferably in an Engineering discipline.

　　Solidworks CAD experience

　　Working knowledge of Microsoft applications including MS Project.

　　Minimum 3 years prior Manufacturing Engineering experience in a medical device or pharmaceutical environment.

　　Strong problem solving skills.

　　Effective communication skills.

　　Self motivated.

　　Ability to work effectively under pressure to meet deadlines.

　　Solid organizational skills-able to handle multiple tasks simultaneously.

　　Nonessential Skills, Experience and Qualifications(not necessary but preferred):

　　Pro-E CAD software experience.

　　CNC swiss programming/machining

　　Machine tooling design

　　Familiarity with ORACLE and Agile Manufacturing applications.

　　Experience in a Lean Manufacturing environment.

　　Six Sigma Greenbelt Certification

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.