Senior Process Engineer

Job TitleResponsible 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 FunctionsWork 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 decisionsDevelop and maintain plans and timelines related to project tasks throughout the process development cycle, taking into account resource constraintsAct as a technical liaison between the cross-functional team and the production facilities, including vendors, for new and existing products and processesLead process-related risk management activities including process FMEAs, as well as support application and design FMEAs related to productsPlan, create, and execute validations (IQ/OQ/PQ) in accordance with FDA and ISO harmonized standards including preparation of technical protocols, reports and feasibility studiesPlan, 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 departmentsInterface with quality and development engineers concerning critical aspects for inspection procedures and gages on new and existing productsCreate 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 functionsProvide engineering support for production facilities, including vendors, to trouble shoot and resolve technical problemsOptimize 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 toolsAttend and contribute to team meetings in conjunction with assigned projectsEvaluate new processing technologiesQualificationsB.S. in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, Packaging Science, or other appropriate engineering disciplineMore than 10 years of relevant experience in the medical device and/or pharmaceutical field, with a demonstrated understanding of industry requirements and regulationsComputer literate & experienced in Microsoft Office applications, D365 experience preferredExperience with process mapping, development, characterization, qualification/validation and capability analysis preferredExperience in 3D modeling and drafting; Solid Works software experience preferredMust fit within the Safeguard Medical cultureCompetenciesSelf-directed, demonstrating ownership and accountabilityDemonstrates the ability to plan, execute, control and deliver on project tasks and overall goalsStrong written and verbal communication skillsTeam-oriented personality with the ability to influence others effectively while contributing to and maintaining a positive environmentEnthusiastic, cooperative, and positive work behaviors essential for a collaborative work environment, including building lasting relationships with production personnel in-house and at vendorsExcellent problem-solving skills, including experience implementing the DMAIC thought process and structured root cause analysisAbility to create process maps and risk documents for identification of process risks and creation of mitigation strategies3D modeling and print creation, for fixture designAbility to independently make sound decisions with available informationAbility to analyze data using statistical methods; MiniTab experience preferredExperience with medical device process transfers, new facility start-ups, and design transfer to production for new products preferredExperience in planning, leading, and executing production site transfers preferredExperience with production facility planning preferredLEAN Manufacturing and Six Sigma Methodology experience preferredExperience with sterilization and packaging validation activities preferredPhysical RequirementsPerforming 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 codeMental RequirementsThis 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 RequirementsSome US and OUS travel may be necessary (<15% travel time)Work EnvironmentThe 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.