Sr. Manufacturing Engineer

　　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.

　　Skills:

　　Non-conformance, 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:

　　Bachelors Degree, preferably in an Engineering discipline.

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

　　Good communication and interaction is critical.

　　Implantable device experience preferred. GMP.

　　Support activities like IQ/PQ/OQ.

　　Dealing with Rework and documentation them without impacting the quality of their products.

　　Solidworks CAD experience.

　　Working knowledge of Microsoft applications including MS Project.

　　Strong problem solving skills.

　　Effective communication skills.

　　Solid organizational skills-able to handle multiple tasks simultaneously.

　　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

　　Experience Level:

　　Expert Level

　　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.