Senior Device Engineer

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeWorks as a device engineering team lead or member/lead of cross-functional teams as well as independent contributor throughout the Combination Product Life Cycle process. Leads or participates in cross-functional teams for design changes design transfer activities continuous improvement projects investigations risk assessments and protocol execution. Responsible for device life cycle management of on-market combination products and implementation of new products. Develops Design History File documents Risk Management documents change management technical impact assessments test plans/ protocols test method validations and data analysis. Leads design changes from initiation through design transfer. Performs or oversees engineering design and development work. Develops design concepts/ideas for product improvements fixtures gages and test methods. Develops prototypes of design concepts for engineering testing and evaluation. Generates or reviews/approves SOPs test protocols engineering test reports and provides laboratory oversight as needed. Responsible for adhering to design controls and documenting all product development work and updates in a Design History ResponsibilitiesLeads or participates in design control change management and risk management activities related to the combination device design and manufacturing process ensuring compliance to all applicable regulations including FDA Regulation and Guidance for Combination ProductsPerform Quality Risk AssessmentsPerforms or oversees biomedical/mechanical engineering design and development work including design changes and product improvements Geometric Design and Tolerancing drawings tolerance stacks risk analyses and engineering analyses. Establishes or reviews/approves specifications and inspection requirements for components products and prototypes of design concepts for engineering testing and evaluationCreates or reviews/ approves SOPs Job Aids test protocols reports and risk-based plans for verification and validation approves/ maintains DHF documents and rationales in support of design changes design transfer investigations information requests and product life cycleSupports Manufacturing QCD Lab QDS Lab Quality Engineering and Quality Assurance with investigations and the qualification of new material/ processes/ equipment to assure reliability requirements are met. Participates in or leads CAPA input and technical support for device changes document updates process changes risk management. Performs assessments for change control and may represent group and product on change control review committee. Accountable for change management projects or investigation actions related to the device design manufacturing process or new/updated standards and test methods fixtures gages challenge samples limit samples simulation devices and engineering prototypes of design conceptsDevelops or collaborates on and adheres to project plans timelines and budgetsLiaison with internal production sites quality regulatory R&D and Tech Transfer/Launch TeamsEstablish and maintain relationships with production sites and key stakeholdersTechnical oversight of other engineersMay require management of cross-functional teams and indirect reportsReports and escalates to leadership as appropriateMay provide training for new hires or contractors and may oversee work conducted by contractors or lab technicians. Other duties as assignedBasic QualificationsExperience in Medical Device or Combination Products Design Controls Production Sustaining Engineering role or related fieldB.S. Degree in Engineering discipline with 7 - 9 years experience M.S. Degree in Engineering discipline with 5 - 7 years experiencePh.D. in Engineering discipline with 3 - 5 years experience(Biomedical Engineering or Mechanical Engineering preferred)Preferred QualificationsThorough understanding and in-depth knowledge of FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 ISO 13485 and ISO 14971 and related standards and EU Medical Device DirectivesUnderstanding of production and production systems in a GMP regulated environmentStrong technical project management critical thinking and problem-solving skills. Proficient in Smartsheet or MS analyzing complex issues for patient/user impactUnderstanding of Human factors and usability engineeringConceptual design skills and experience with a variety of manufacturing methods (e.g. injection molding machining etc.)Proficiency in SolidWorks design software Mathcad MindManager and other general computer software such as word processing spreadsheets presentations flow charts etc. Strong laboratory skills such as component inspection or failure analysis mechanical testing etc. with a good understanding of GMP documentation and data integrity mathematical analytical and reasoning skillsStrong innovation skills and creativity astutenessStrong teamwork and organizational skillsStrong written and oral communicationKnowledge of Design for Reliability and Manufacturing (DRM) and robust device design practicesAbility to prioritize multiple responsibilities and to work on multiple complex technical projects simultaneouslyExperience with FDA investigators and other global regulatory agencies in the front room or providing back room support#LI-onsite #LI-BM1#LI-onsite #LI-BM1#