Senior / Staff Process / Manufacturing Engineer

Manufacturing EngineerServes as the technical expert for internal and external manufacturing processes, ensuring they are robust, validated, and ready to support product launch and scale-up. This role reviews concepts and supports the development and build-up of manufacturing equipment. The engineer partners with cross-functional teams and suppliers to manage risk, maintain product quality, and drive continuous process improvement.ResponsibilitiesTechnical SME and support for internal and external manufacturing processes ensuring alignment with product requirementsEnsure readiness for pilot builds, commercial scale-up and capacity expansionDrive timelines aligned to product launch milestonesOwn deliverables during scale-upDefine and ensure validation strategy for equipment (IQ/OQ/PQ) and support process performance validationSupport or lead internal process or equipment validation effortsAssess internal and external technical capabilityEvaluation impact of change requests, process improvements and raw material substitutionPerform on-site technical reviews and gap assessmentsLead process FMEA and risk mitigation with supplier teamsEnsure traceability from design inputs to production controlsDraft, review and approve protocols and reportsAnalyze yield, scrap and defect dataReview deviation investigations and CAPAs impacting product qualityIdentify process optimization opportunitiesEvaluate second-source suppliers for risk mitigation and assist with site transfers and line expansionAuthor technical justification for change controls and supplier RFC as requiredSkills RequiredExcellent mechanical aptitude and good attention to detailsStrong cross-functional leadership, communication, project management, and ability to work under tight deadlinesExcellent oral and written communication skills as well as strong interpersonal skillsWell versed in medical device regulatory requirements from Food and Drug Administration (FDA), European Medicines Agency (EMA), etc. and regulatory standardsEducation and ExperienceBachelor's degree in Mechanical, Electrical, Industrial or Mechatronics Engineering or equivalentMaster's or higher-level degree in Engineering, Physics or related field, or demonstrated equivalent experience.10+ years of experience in design/development/troubleshooting of medical devices and/or electromechanical systemsHands-on experience with process and equipment validation (IQ/OQ/PQ/PPQ), including authoring and approving protocols and reportsExperience managing suppliers through pilot builds and commercial scale-up, including supplier capability assessments and on-site auditsExperience with risk management and problem-solving tools, including PFMEA, root cause analysis and CAPAExperience working in compliance with GMP and GDP regulationsExperience in numerical modeling including CFDExperience in statistical analysis, including use of tools such as JMP for data analysis and experimental designExperience designing and troubleshooting electronic and mechanical systemsExperience with CAD software (SolidWorks) including preparation of engineering drawings using GD&T preferredExperience in designing injection molded parts preferredExperience programming in LabVIEW a plusPhysical RequirementsProlonged periods of sitting at a desk and working on a computerPotentially prolonged periods standingMust be able to lift up to 15 pounds at timesMust be willing to travelCompensation & EEOThe base salary for this role ranges between $164,000-209,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes a discretionary bonus program, diverse health and other benefits.Nova Pneuma, Inc. is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.