{"id":4295912,"url":"https://alion.io/job/switchback-medical-sr-rd-engineer","title":"Sr R&D Engineer","company":{"id":3872603,"name":"Switchback Medical","domain":"switchbackmedical.com","url":"https://alion.io/company/switchbackmedical","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Paylocity","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Brooklyn Park, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":105000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"Design Controls","optional":false},{"name":"Design of Experiments","optional":false},{"name":"GD&T","optional":false},{"name":"ISO 10993","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Minitab","optional":false},{"name":"SolidWorks","optional":false}],"status":"live","first_seen_at":"2026-11-13T20:20:47Z","employer_posted_date":"2026-11-14","last_verified_at":"2026-11-14T08:45:24Z","board_verified":true,"closed_at":null,"days_open":0,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":0},"description":"Description\nSummary:\nThe Senior R&D Engineer is a hands-on technical contributor who independently leads the design, development, and transfer to manufacturing of catheter-based medical devices, components, and assemblies for LightningCath customers. Working under general direction, this role takes products from concept and feasibility through design verification and process validation, applies a working knowledge of polymer materials and catheter construction methods, owns defined project workstreams, and provides technical direction to technicians, operators, and less experienced engineers.\nEssential Duties and Responsibilities (but are not limited to):\nDesigns and develops catheter shafts, components, and assemblies, including material selection and construction methods such as extrusion, braiding, coiling, reflow/lamination, tipping, bonding, and forming.\nBuilds and iterates prototypes hands-on in the lab; designs and builds test fixtures, tooling, and assembly aids.\nCreates and maintains 3D CAD models and released drawings with appropriate tolerancing and GD&T.\nDevelops and qualifies test methods (e.g., tensile, torque, kink, burst, flow, track/push, dimensional) and executes design verification testing, analyzing results with appropriate statistical methods.\nEstablishes new and/or improved processes based on product and design criteria.\nDevelops manufacturing procedures and travelers, performs process characterization, and aids in process validation (IQ/OQ/PQ) to transfer processes to manufacturing.\nWorks within the team environment to solve quality and design issues, leading root cause investigations and supporting NCMR and CAPA activities.\nProvides technical guidance and work direction to technicians and operators, and mentors junior engineers.\nWorks directly with customers to define requirements, communicate technical status, and meet their deliverables and timelines.\nTakes part in the business development process, especially new product introduction for new and existing customers, by scoping technical work and estimating effort for customer proposals.\nWorks with suppliers to source and qualify materials, components, and outside processes.\nMaintains knowledge of new developments in catheter materials, manufacturing, and design technologies.\nRequirements\nEducation/Experience:\nBachelor’s degree in Mechanical, Biomedical, Plastics/Polymer, or related engineering discipline. \n5+ years of engineering experience.\n3+ years of medical device product development experience, with hands-on catheter design or process development strongly preferred.\nKnowledge, Skills, and Abilities:\nRequired\nProficiency in 3D CAD for part and assembly modeling and drawing creation.\nWorking knowledge of catheter materials (e.g., Pebax, nylon, polyurethanes, PTFE, polyimide, stainless steel, nitinol) and catheter construction and assembly processes.\nWorking knowledge of design controls, risk management, and quality system requirements under ISO 13485, 21 CFR 820 (QMSR), and ISO 14971.\nExperience writing and executing test protocols and reports, and applying statistical analysis to engineering data.\nStrong technical writing and verbal communication skills, including direct communication with customers.\nAbility to manage multiple projects and priorities in a fast-paced, small-company environment.\nPreferred\nExperience with Onshape and SolidWorks.\nExperience with 3D printed parts and assemblies.\nExperience in a contract design and manufacturing (CDMO) or customer-facing development environment.\nExperience with process validation (IQ/OQ/PQ) and transfer of processes to manufacturing.\nFamiliarity with sterilization (EO, gamma) and biocompatibility (ISO 10993) considerations as they affect design and material selection.\nExperience with statistical software (e.g., Minitab) and design of experiments (DOE).\nLean, Six Sigma, or DFM/DFA training.\nWorking Conditions:\nWork is performed in an office, laboratory, and cleanroom manufacturing environment; must be able to follow gowning and cleanroom procedures.\nFine manual dexterity and close visual work, including use of microscopes, for prototyping and assembly.\nOccasional travel to customer and supplier sites (up to approximately 10%).\nSummary of Benefits\nGroup health & welfare benefits: Options for Medical, Dental and Vision insurance, Health Savings Account (requires participation in eligible medical plan).\nCompany-paid benefits: Employee Life Insurance & Accidental Death & Dismemberment (AD&D), Long Term Disability (LTD), Short Term Disability (STD).\n401(k) Plan with company match\nPaid Time Off\nPaid Parental Leave\nPaid Holidays \nBenefits and incentive compensation may be subject to generally applicable eligibility, waiting period, contribution, and other requirements and conditions.\nCompensation\nThe typical base pay range for this role is between $105,000-140,000/year. 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