Senior Npd EngineerThe Senior NPD Engineer is responsible for leading the design and development of complex medical devices from concept through commercialization. This role focuses on product architecture, detailed design, and technical problem solving to deliver innovative, high-quality solutions that meet customer and business needs.Operating with a high level of independence and technical expertise, the Senior Engineer leads key design efforts, collaborates closely with customers and cross-functional teams, and ensures designs are robust, manufacturable, and compliant with regulatory requirements. This role also plays a critical part in mentoring engineers and driving continuous improvement in product design practices.Role ResponsibilitiesProduct Design & DevelopmentLead design and development activities across the product lifecycle, from concept through design verification and validationTranslate customer requirements into detailed product designs, engineering specifications, and functional requirementsDevelop product architectures, component designs, and assemblies using sound engineering principlesEnsure designs meet performance, reliability, manufacturability, and regulatory requirementsDrive innovation through development of new product concepts, technologies, and design solutionsEvaluates and integrates new materials, technologies, and design approaches to enhance product capability.Engineering Analysis & Problem SolvingSolve complex design challenges using advanced engineering analysis, simulation, and testing methodologiesDesign and execute experiments, testing, and analysis to validate product performance and design robustnessApply statistical and analytical tools to support design decisions and optimize product performanceIdentify technical risks early and lead development of mitigation strategiesEvaluate and integrate new materials, technologies, and design approachesDesign Controls & ComplianceApply and ensure adherence to design control processes, including Design History Files (DHF), risk management, and verification/validation activitiesEnsure compliance with regulatory and quality requirements throughout the design processChange Management & DocumentationLead engineering change activities, ensuring proper documentation and implementationSupport accurate and thorough technical documentation across the product lifecycleCross-Functional Collaboration & Customer EngagementCollaborate with manufacturing, process engineering, quality, and regulatory teams to ensure successful design transfer and product launchDrive design for manufacturability (DFM) and design for assembly (DFA) throughout developmentPartner with customers to refine requirements, present design solutions, and support technical discussionsLeadership & Project OwnershipLead significant portions of projects or own key design workstreams with full accountabilityMentor and provide technical guidance to engineers and designers, supporting team capability developmentProcess Improvement & Business SupportIdentify opportunities to improve design processes, tools, and methodologiesContribute to early program planning and quoting by providing input on technical feasibility, risks, and timelinesProvide input into quotes to ensure accuracy and quick turnaroundPerforms other duties as assigned in support of business and organizational objectives.RequirementsBachelor's degree in Engineering with 5–8 years of medical device design experienceStrong knowledge of design controls, product development, and verification/validation methodsProficiency in 3D CAD (SolidWorks preferred) and strong understanding of GD&T/draftingExperience with analytical and statistical tools (DOE, tolerance analysis, etc.)Experience in regulated environmentsStrong technical writing and documentation skillsExcellent communication and cross-functional collaboration skillsDemonstrated ability to lead design efforts or major workstreams independentlyProven ability to mentor junior engineers and guide technical workSix Sigma Green/Black Belt (preferred)Why Join Biomerics?At Biomerics, you will be part of a collaborative and growth-oriented organization dedicated to improving lives through innovation and manufacturing excellence.
We value individuals who are passionate about building strategic customer partnerships and driving operational and commercial success within the medical device industry.Benefits: Medical/Dental/Vision Insurance, Short-Term Disability, Long-Term Disability, Life Insurance, Paid Vacation Days, Paid Holidays, 401k.The salary estimates are estimates from this job board and not a guarantee from Biomerics' salary range.Biomerics does not accept non-solicited resumes or candidate submittals from search/recruiting agencies that are not already on Biomerics' approved agency list. Unsolicited resumes or candidate information submitted to Biomerics by search/recruiting agencies not already on Biomerics approved agency list shall become the property of Biomerics, and if Biomerics subsequently hire the candidate, Biomerics shall not owe any fee to the submitting agency.