Medical Device Risk Management Jobs in Fort Mill, SC

Job Type
Full-time
Description
Job Summary
Responsible for leading and executing the development, sustainment, and validation of 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, including work instructions and process FMEAs for both internal and supplier-based processes. Also responsible for supporting cross-functional projects related to existing and new products, as necessary, including recommended changes to specifications based on manufacturing process input. Will use a wide degree of creativity and latitude to accomplish varied and complicated tasks relying on experience and judgement to plan and accomplish goals.
Essential Job Functions
• 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 plans and timelines related to project tasks throughout the process development cycle, taking into account resource constraints
• 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
• Plan, lead, and facilitate 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 device (per FDA 21 CFR part 820 and ISO 13485)
• Develop 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 trouble shoot and resolve technical problems
• Optimize product, processes, tooling and/or equipment that meet customer needs, technical design goals, regulatory / quality requirements, and cost / efficiency goals through use of Lean / Six Sigma techniques and tools
• Attend and contribute to team meetings in conjunction with assigned projects
• Evaluate new processing technologies
Qualifications
• B.S. in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or other appropriate engineering discipline
• More than 10 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, D365 experience preferred
• Experience with process mapping, development, characterization, qualification/validation and capability analysis preferred
• Experience in 3D modeling and drafting; Solid Works software experience preferred
• Must fit within the Safeguard Medical culture
Competencies
• Self-directed, demonstrating ownership and accountability
• Demonstrates the ability to plan, execute, control and deliver on project tasks and overall goals
• Strong written and verbal communication skills
• Team-oriented personality with the ability to influence others effectively while contributing to and maintaining a positive environment
• Enthusiastic, cooperative, and positive work behaviors essential for a collaborative work environment, including building lasting relationships with production personnel in-house and at vendors
• Excellent problem-solving skills, including experience implementing the DMAIC thought process and structured root cause analysis
• 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 independently make sound decisions with available information
• Ability to analyze data using statistical methods; MiniTab experience preferred
• Experience with medical device process transfers, new facility start-ups, and design transfer to production for new products preferred
• Experience in planning, leading, and executing production site transfers preferred
• Experience with production facility planning preferred
• LEAN Manufacturing and Six Sigma Methodology experience preferred
• Experience with sterilization and packaging validation activities preferred
Physical Requirements
Performing the duties of this job regularly involves: (1) sitting, (2) standing; (3) walking; (4) hearing/listening (5) repetitive hand movement; (15) vision requirements - close vision, adjust focus, color code
Mental Requirements
This position requires the ability to: (1) maintain an appropriate work pace; (2) comprehend and follow instructions; (3) exercise logic and reasoning; (4) organize and prioritize; (5) read; (6) compose written communication; (7) communicate verbally; (8) problem solve (9) make decisions; (10) count and compute (11) analyze and interpret data; (12) multi-task/re-direct; (13) experience numerous interruptions, (14) This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.
Other Requirements
Some US and OUS travel may be necessary (<15>
Work Environment
The noise level in the work environment is usually quiet to moderate when in the office setting and may be loud when in a lab or production environment.