Position Details

Type Full-Time

Experience senior

Exp. Years 5+ years

Education Bachelor's degree in Engineering or related field

Category Engineering (Non-Software)

About this role

Senior Process Engineer to join the NPI team to develop and launch new products; manages lifecycle from feasibility to market release; leads new manufacturing processes and equipment; collaborates across R&D, Quality and other departments.

Key Responsibilities

Lead research, development, and evaluation of materials, components, assemblies, and processes for new product portfolio
Plan, implement, and coordinate NPIs including product and process design, specifications, validations, equipment layout, production procedures, and procurement of materials
Design and introduce new manufacturing processes, automation, and equipment to increase capabilities and efficiencies
Develop and own critical processes for complex devices in pilot and production environments
Design and execute structured experimental plans for data-based decision-making and continuous improvement

Technical Overview

Focus on process development and validation for complex devices, including pilot and production environments; apply lean principles; deliver deliverables such as IQ, FMEA, GR&R, TMV; manage experimental design and data-driven decisions.

Ideal Candidate

The ideal candidate is a senior process engineer with 5+ years in medical device manufacturing, strong in process validation and lean manufacturing, capable of leading NPI processes and cross-functional teams.

Must-Have Skills

Bachelor's degree in Engineering or related field5+ years of relevant work experienceExperience in process design/development and product design for manufacturabilityExperience with process validationExperience with FMEALean manufacturing principlesRoot cause analysisMS Office proficiency

Nice-to-Have Skills

Experience in the medical device industryLean or Six Sigma trainingStrong analytical skills in business needs assessment and solution implementation

Tools & Platforms

MS OfficeAutomation

Required Skills

process designprocess developmentproduct design for manufacturabilityprocess validationFMEAFailure Mode and Effects Analysislean manufacturingdesign of experimentsGR&RGauge R&Rinstallation qualificationIQTMVTest Method Validationstatistical analysisroot cause analysisMS Officeautomationequipment validationquality systems

Hard Skills

Process designProcess developmentProcess validationFMEAFailure Mode and Effects AnalysisLean manufacturingDesign of ExperimentsGauge R&RGR&RInstallation QualificationIQTest Method ValidationTMVStatistical analysisRoot cause analysisMS OfficeAutomationEquipment validationQuality SystemsValidation strategiesDesign for ManufacturabilityProcess development for manufacturability

Soft Skills

leadershipmentorshipcommunicationproblem-solvingteam collaborationplanninganalytical thinkingtime management

Certifications

Preferred

Lean Six Sigma training

Industry & Role

Industry Healthcare & Medical

Job Function Lead development and transfer of manufacturing processes for medical devices in an NPI environment

Role Subtype process engineer

Keywords for Your Resume

senior process engineerprocess validationdesign of experimentslean manufacturingFMEAFailure Mode and Effects AnalysisGR&RGauge R&RIQInstallation QualificationTMVTest Method Validationstatistical analysisroot cause analysisMS Officeautomationequipment validationquality systemsnew product introductionNPIpilot and productionmanufacturing processescross-functional collaborationvalidation strategies

Deal Breakers

Bachelor's degree in engineering required, 5+ years of relevant work experience, Experience with process validation and FMEA, Medical device industry experience

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