Principal NPI Manufacturing Engineer-Medical Device

Principal NPI Manufacturing Engineer

At HiArc, we believe clients don't need another vendor; they need a strategic partner who gets it. One who listens harder, thinks deeper, and builds smarter—around their needs, products, and goals. HiArc engineers and manufactures complex medical technologies with one goal in mind: creating the perfect fit for our clients. No off-the-shelf thinking. No compromises. Just a tailored, high-performance solution our clients need, the way they need it.

That's why HiArc is the most client-centered partner in the market. We fuse design, engineering, and manufacturing into a seamless, collaborative process—crafted entirely around our clients. We operate as an extension of our clients' teams, de-risking their processes and accelerating their path to market. And the result is a solution you won't find anywhere else.

Join our team! We hire experts in hardware and software design, robotics, optics, fluidics, chemistry integration, motion and thermal control, risk management, supply chain management, performance testing, advanced manufacturing techniques, finance, human resources, sales, and marketing.

The Principal NPI Manufacturing Engineer supports diverse technologies in the manufacturing of high quality analytical and medical instruments at competitive cost. You will coordinate, plan, review and improve manufacturing processes of New Product Introductions ensuring production capacity, efficiency, and quality. The Manufacturing Engineer must effectively build cooperative relationships with Design, Quality, Production, Configuration Management, Supply based engineering, as well as other internal and external groups.

You must also demonstrate attention to detail, Lean Principles, process capability, strong analytical skills, and excellent verbal / written communication skills.

• Review, evaluate and develop manufacturing processes with man, machine, material, and methods considered. Determining optimal sequence of operations to reduce time cycles, simplify tasks and reduce total costs.
• Improve manufacturing efficiencies by analyzing and planning workflow, space requirements, equipment, and floor layout.
• Prepare and support accurate parts lists, bills of materials, assembly trees, and outsourcing opportunities.
• Develop, evaluate and specify tools, fixtures, equipment and jigs for the manufacture of systems, assemblies, components, etc. assuring optimum operations for production areas. Recommend and initiate modifications to optimize production conditions.
• Identify and recommends test processes, procedures and equipment, coordinating with Systems and Quality Engineering departments.
• Interface and contribute to coordinating efforts with other engineering departments and vendors to assure efficient, cost-effective production operations.
• Develop, evaluate, and review instructions, specifications and methods to support the product life cycle transitions from development into production.
• Prepare product and process reports by collecting, analyzing, and summarizing information and trends.
• Provide manufacturing decision-making information to support capacity planning for labor, production schedules, and estimating future requirements.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.
• Assure product and process quality by designing test methods; testing finished product and process capabilities; establishing standards; confirming manufacturing processes.
• Assist design and development projects by training and guiding manufacturing personnel.

• Product and Process Design & Development
• Process Planning & Development (capacity planning floor layout, material flows, capabilities Cp, Cpk)
• Process Documentation and Work Instructions
• Human Factors, Ergonomics and Safety
• Production tooling and equipment selection, development and qualification
• Design for (Manufacturing, Assembly, Test, Maintenance, etc.)
• Engineering drawing (GD&T) ANSI Y14.5, models, prints,
• Enterprise-wide Systems Integration (PLM, MRP, MES, ERP, etc.)
• Quality Systems,…