Process Engineer II

Safeguard Medical•Huntersville, NC

21d

About The Position

Responsible for developing, sustaining, and validating processes and equipment used in the manufacture of medical device product(s) including determination of process flow, fixture/tooling development, and generation of engineering and production documentation, such as work instructions and process FMEAs for both internal and supplier-based processes. This role also supports cross-functional projects related to existing and new products, providing manufacturing process input for specification changes. The position requires a high degree of creativity and latitude, relying on experience and judgment to plan and accomplish goals.

Requirements

B.S. in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or other appropriate engineering discipline.
More than 3 years of relevant experience in the medical device and/or pharmaceutical field, with a demonstrated understanding of industry requirements and regulations.
Computer literate & experienced in Microsoft Office applications.

Nice To Haves

Experience with process mapping, development, characterization, qualification/validation and capability analysis.
Experience in 3D modeling and drafting; Solid Works or Solid Edge software experience.
Must fit within the Safeguard Medical culture.
Ability to create process maps and risk documents for identification of process risks and creation of mitigation strategies.
3D modeling and print creation, for fixture design.
Ability to analyze data using statistical methods; MiniTab experience.
Experience executing production site transfers, new product transfers to production, or facility design.
LEAN Manufacturing and Six Sigma Methodology experience.
Experience with sterilization and packaging validation activities.

Responsibilities

Work with production facilities and vendors to develop, evaluate, document, implement, and improve manufacturing processes throughout the product life cycle, including process control techniques, related fixtures and tooling, training personnel when required, and estimation of staffing requirements, production times, and relative costs to provide data for production decisions.
Develop and maintain timelines related to project tasks throughout the process development cycle or related projects.
Act as a technical liaison between the cross-functional team and the production facilities, including vendors, for new and existing products and processes.
Lead process-related risk management activities including process FMEAs, as well as support application and design FMEAs related to products.
Plan, create, and execute validations (IQ/OQ/PQ) in accordance with FDA and ISO harmonized standards including preparation of technical protocols, reports, and feasibility studies.
Execute on production transfers, including production floor layout and facility planning activities (equipment spacing, utilities, etc.).
Comply with all SOP and regulatory requirements pertaining to the development of medical devices (per FDA 21 CFR part 820 and ISO 13485).
Implement appropriate preventative maintenance plans, and coordinate calibration and preventative maintenance activities with Quality and Production departments.
Interface with quality and development engineers concerning critical aspects for inspection procedures and gages on new and existing products.
Create and maintain accurate documentation of process specifications, work instructions, tooling drawings, design concepts, shop orders, and concepts in accordance with the R&D and quality assurance functions.
Provide engineering support for production facilities, including vendors, to troubleshoot and resolve technical problems.
Attend and contribute to team meetings in conjunction with assigned projects.